Systems Engineer

HR Transaction Delivery Analyst

Medical Affairs Lead

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Digital Marketing Specialist

Staff Engineer – Devices

Quality Control Supervisor

Analytical Quality Assurance Specialist

Responsibilities: <ul><li>Respond, manage, and escalate (as needed) technical support requests via the ticketing system, telephone calls, and emails either directly or using remote support tools.</li><li>Responsible for supporting Business user end point devices (Laptops/desktops/Smart phones/Tablets /video conferencing services) either directly or using remote support tools on as-needed basis.</li><li>Ensure compliance of regulatory requirements including cGMP standards and site-specific SOPs when completing assigned functional activities.</li><li>Manage and maintain analytical laboratory and computerized manufacturing control systems in a GMP environment according to established regulatory requirements.</li><li>Perform L1 tasks on Server, Network and Telecom Infrastructure in USA &amp; Canada as needed.</li><li>Assist Core teams in performing L1 troubleshooting tasks on Security tools, technologies &amp; platforms like Crowdstrike, Zscaler, Zero Trust, Privileged access management.</li><li>Maintain inventories of endpoint devices, GMP assets and applications.</li><li>Ensure 100% compliance with the GMP Policies and Procedures.</li></ul> Operations: <ul><li>Handle day to day end user support tickets. Provides IT support to VIP users.</li><li>Work with central IT teams to resolve issues reported via helpdesk system.</li><li>Owns end-to-end responsibility for resolving issues in a timely manner.</li><li>Provides updates on Infrastructure health and corrective/preventive actions.</li><li>Maintains an up-to-date inventory of endpoint devices, servers, GMP assets, OT devices and Network devices.</li><li>Flexible to work in a multi-shift operation environment.&nbsp;</li><li>Can be onsite on need basis to assist during any crisis in off-business hours.</li><li>Ensure site IT SOPs are updated and supports site QA and CSV on GMP tasks.</li></ul> Requirements: Education Qualifications:&nbsp; <ul><li>Bachelor’s degree (IT) or similar Desired Certifications.</li><li>Certifications (preferred) – Current JNCIE-ENT, JNCIE, or CCIE certification/ CCNP, CEH, CISSP, MCSA etc.</li></ul> Experience Required: <ul><li>3 – 5 years’ experience working in a GMP compliant pharmaceutical laboratory/manufacturing environment.</li><li>Working Knowledge of Cisco, Juniper, Aruba Technologies &amp; Architectures (examples- Cloud &amp; Cloud Security, Networking- Network Segmentation, Patching, Next-Gen AV, Avaya VOIP, Teams based Conferencing systems)</li><li>Experience managing and maintaining servers, LAN, IP Phone and WAN systems; Switches/ Routers/ Access Points, VPNs; Knowledge of IT-OT Network Segregation.</li><li>Working knowledge of networking concepts such as Routing, Switching, VLANs, VPNs, DHCP and DNS.</li><li>Hands-on experience with Windows 10/11, Microsoft Office tools, common business applications, digital signing applications, Adobe software, Apple devices and L1 knowledge of Windows Server operating systems, Virtualization Hypervisors like VMWare and Wireless Networking devices like Aruba/HPE.</li><li>Has good knowledge for troubleshooting Microsoft 365 and Microsoft Teams rooms (conferencing systems)</li><li>Oversee and ensure timely repair/replacement of faulty hardware including endpoint devices, network hardware and appliances.</li><li>Well versed on GMP Infrastructure and Applications used in Manufacturing and Laboratories.</li><li>Well versed with GMP Procedures</li></ul>

Responsibilities: <ul><li>The HR Transaction Delivery Analyst is responsible for managing and executing transactions in an efficient and timely manner and supporting the transactional operations within the GBS (Global Business Services) center.</li><li>This role will be based out of the Cluj, Romania / Manila, Philippines / TBD, Mexico office (select applicable location) and will involve performing detailed analysis of transactional data, assisting in the processing of financial transactions, and contributing to the improvement of transactional processes such as accounts payable, accounts receivable, payroll, and other related services.</li></ul> Major Responsibilities <ul><li>Assist in processing financial transactions, ensuring accuracy, timeliness, and compliance with company policies and regulations.</li><li>Analyze transactional data to identify trends, discrepancies, and opportunities for process improvement.</li><li>Identify process gaps and recommend enhancements for improved efficiency.</li><li>Conduct quality checks and audits to verify data accuracy.</li><li>Track transaction case volume and workload in coordination with the team lead.</li><li>Assist the Transaction Delivery Manager in monitoring and reporting on performance metrics and service level agreements (SLAs).</li><li>Collaborate with team members to resolve transactional issues and respond to stakeholder queries.</li><li>Contribute to developing and implementing policies and procedures to standardize transactional processes.</li><li>Participate in continuous improvement initiatives, suggesting enhancements to systems and workflows.</li><li>Assist in preparing financial reports and documentation for audits.</li><li>Maintain knowledge of relevant financial regulations, accounting standards, and best practices.</li><li>Support the transition of transactional services to the shared services center, including data migration and system integration.</li><li>Serve as a secondary contact for HR Business Partners (HRBBPs), Centers of Excellence (COEs), and escalations as needed.</li><li>Ensure timely resolution of complaints to meet compliance requirements.</li><li>Provide training and support to new team members and end-users of transactional systems.</li><li>Collaborate with IT and other departments to optimize transactional systems in alignment with business needs.</li></ul> Requirements: <ul><li>A bachelor’s degree in accounting, Finance, Business Administration, or a related field.</li><li>A minimum of 2 years of experience in a transactional services or financial analysis role.</li><li>Strong analytical and data analysis skills, with proficiency in Excel and other data analysis tools.</li><li>Experience with Workday and ServiceNow platforms and services.</li><li>Familiarity with financial processes and systems, including ERP and HRIS software.</li><li>Attention to detail and a commitment to accuracy and quality in transaction processing.</li><li>Good communication and interpersonal skills, with the ability to work effectively in a team environment.</li><li>Ability to manage multiple tasks and prioritize work in a fast-paced environment.</li><li>Knowledge of financial regulations and accounting standards relevant to transactional services.</li></ul>

Responsibilities: <ul><li>To effectively lead the Medical Affairs activities for segment across therapy areas, providing effective business enablement and high edge scientific activities towards achieving disease and therapy area leadership and enhancing access of products in disease and therapy areas of interest.</li><li>Help in evaluation of New Products for therapy prominence working portfolio and strategy team and marketing team.</li><li>Build connect with KOLs (Key Opinion Leaders) in shaping Therapy understanding and molecule understanding. CME/Ad board conduct ((Continuing Medical Education (CME)/(Medical) Advisory Board)), support guidelines , consensus etc.</li><li>To have scientific activities those are considered differentiated and purposeful for targeted audience.</li><li>Identifying need and planning evidence generation and post marketing studies.</li><li>Guide marketing teams in ensuring proper medical inputs and activities are delivered as per compliance.</li><li>Medico-marketing Support</li><li>Compliance in medico marketing activity</li><li>Evidence generation activities</li><li>Evaluation of New Products</li><li>Training and Development</li><li>Scientific Updates</li><li>Activities for Digital Platforms &amp; Other activities</li><li>Support Medical writing , Publication and communication</li></ul> Requirements: <ul><li>MD (Pharmacology/Medicine) / MBBS</li></ul> Experience: <ul><li>5-8 year in Medical Affairs -</li><li>Freshers with exceptional academic qualifications will be considered</li></ul> Skills: <ul><li>MS Office</li><li>Excellent written &amp; oral communication skills</li><li>Disease/Therapy Knowledge</li><li>Business Acumen</li><li>Excellent Relationship Building Skills</li><li>Broad Understanding of Medical Affairs&nbsp;</li><li>Confidence to interact with Internal &amp; External Stakeholders</li></ul>

Reponsibilities: Product Level Strategy <ul><li>Market data and internal financials</li><li>Strategy (gain share, hold share, rationalize volume, improve price, etc.)</li><li>Target share</li><li>Inventory targets based on market dynamics, product strategy, etc.</li><li>Provides input for Product Champions</li><li>Decision-making for Day-to-day Commercial Operations</li><li>Incorporate Product Strategies while leading/making the following decisions:</li><li>Order processing</li><li>ROFR responses</li><li>New business bids</li></ul> Rolling 12-month forecasts <ul><li>New Product Intel and Near-term Launch Evaluation &amp; Tracking</li><li>Maintain master database of future product pipeline information at the customer level.</li><li>Share with Portfolio as needed.</li><li>Assess the right frequency of pricing &amp; volume intel requirements</li><li>Interpret the accuracy of intel based on existing data points and those gathered via subscriber information (IQVIA, export data, etc.)</li><li>Rolling 12-month New Product Launch Prioritization and Planning</li></ul> Tracking results vs. business case on new launches <ul><li>Provide leadership for Product Management, Pricing/Contracts, Customer Service, Forecasting and Marketing</li><li>Identify/execute process improvements, including IT solutions</li><li>Manage all aspects of OTB strategies &amp; tactics (price, vol, production)</li><li>Improve UPS execution and shipping costs while analyzing other 3PLs</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor’s or master’s degree preferred</li><li>10 plus years related work experience in the pharmaceutical industry, preferably generics</li><li>Excellent computer skills, including data collection experience</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Industry/Customer recognition</li><li>Financial acumen</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific (e.g. coaching, negotiation, calibration, technical writing etc.)</li><li>Interpersonal Skills - Focuses on solving conflict; Maintains confidentiality; works well in a collaborative environment</li><li>Adapts to changes; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes or unexpected events. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements (e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.)</li><li>General Office environment</li><li>Occasional Travel</li></ul>

Responsibilities: Distribution Operations <ul><li>Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory.</li><li>Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries.</li><li>Maintain and administers all departmental policies, SOP’s and training.</li></ul> Compliance and Audit <ul><li>Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li></ul> Cross-Functional Support <ul><li>Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul> Requirements: Education &amp; Experience	 <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Minimum of a Bachelor’s Degree, preferably with a Business, Technical and /or Supply Chain focus.</li><li>Minimum of 8 years’ experience in Supply Chain Operations.</li><li>Project management experience preferred.</li><li>Experience with Six Sigma/Process excellence tools, training or certification.</li><li>Shipment of Hazardous Material transportation certification.</li><li>APIC’s certification preferred.</li><li>Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of US and international transportation and distribution practices.</li><li>Knowledge of Code of Federal regulations Title 21 part 210 and 211, and DEA rules and regulations for distribution/storage/manufacture of controlled substances is a must.</li><li>Must have working knowledge of serial shipping container code (SSCC).</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Strong communication, collaboration, and organizational skills.</li><li>Results oriented - identifies issues and drives the decision process.</li><li>Ability to effectively challenge assumptions/decisions and support the minority viewpoint when needed.</li><li>Influence management – ability to work cross-functionally at all levels.</li><li>Creative innovation skills, excellent influencing skills, and strong design and visualization capability.</li><li>Deals well with conflict – negotiator, mediator.</li><li>Collaborates with team members on plans (and holds team members accountable).</li><li>Good problem-solving skills, sound judgment.</li><li>Take decisive action and deliver tangible results in a fast-paced cross-functional organization and highly competitive industry.</li></ul> Physical Requirements: <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Able to sit and stand for up to 8 hours.</li><li>Able to walk through production areas.</li><li>Able to lift up to 30 lbs.</li><li>Distribution Operations Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory. Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries. Maintain and administers all departmental policies, SOP’s and training.</li><li>Compliance and Audit Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li><li>Cross-Functional Support Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Role Description:&nbsp; <ul><li>Our client is seeking a dynamic and results-driven Digital Marketing Specialist to join our team on a freelance, project-based basis.</li><li>The ideal candidate will have hands-on experience in digital marketing, influencer marketing, and new media channels like podcasts, with a strong background in performance marketing.</li><li>This role offers an exciting opportunity to work with a growing company in the following industries: OTC Healthcare/Consumer Goods/Health and Wellness/E-commerce.</li></ul> Responsibilities: <ul><li>Partner with brand marketers to understand brand strategy, tactical plans, campaign requirements, data needs, and operational support associated with their digital marketing efforts</li><li>Plan and carry out marketing and promotional activities for the brand.</li><li>Ensure timely and compliant delivery of operational responsibilities in accordance with project milestones.</li><li>Serve as a subject matter expert for digital marketing best practices, internal processes, and systems related to digital marketing.</li><li>Help brand marketers ensure adequate data capturing and reporting are in place for all digital marketing initiatives.</li><li>Facilitate continued educational/training opportunities for internal marketing stakeholders and external agency teams</li><li>Gather future business requirements and represent the voice of the brand as additional digital marketing capabilities/platforms are established.</li><li>Cultivate strong partnerships with external agency teams, suppliers, and vendors in support of Brand and/or Digital Operations efforts.</li><li>Lead and execute media plans; Identify and optimize digital channel mix to help grow the brands.</li><li>Oversee all digital paid advertisements and third-party digital vendor management.</li><li>Analyze data by mapping current digital tactics to identify gaps, opportunities, and insights to optimize spend, performance &amp; ROI</li><li>Proficiency in core marketing capabilities such as digital creative development, segmentation, investment optimization, etc.</li><li>Experience in managing multiple external agency partners and internal marketing partners to meet deadlines in alignment with SOWs.</li><li>Work with overseas counterparts to ensure alignment of brand objectives.</li><li>Plan, conceptualize, and develop new product launches.</li><li>Manage media communication, advertising, and campaign/promotion on both offline and online (social media, Facebook, Instagram)</li><li>Manage brand presence in social networking sites including Facebook, Twitter, and other relevant blogs, sites, e-commerce, and forums</li><li>Monitor social media for conversations and trends related to company brand and feedback insights to the Regional to align overall business strategy</li><li>Measure the impact of social media programs; analyze, review and report on the effectiveness of our company’s social&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree (or) masters degree in marketing or related fields.</li><li>6+ years of relevant experience, preferable within the bio/pharma industry with at least 5 years of digital marketing experience</li><li>Exceptionally strong analytical skills, Communication Skills with the ability to evaluate KPIs, present learnings based on data and optimize</li><li>In-depth knowledge of digital marketing within the pharmaceutical or healthcare industry.</li><li>Freelance, Project-Based Work: Must be willing to work on a freelance, project basis, with flexibility on timelines and deliverables.</li><li>Operational Experience: Must have direct operational experience in digital marketing, influencer marketing, and new media, including podcasts.</li><li>Performance Marketing Expertise: Proven experience in performance marketing, with a focus on driving measurable results like conversions and ROI.</li><li>Proficiency in managing paid campaigns across multiple platforms (Google Ads, Meta, TikTok).</li><li>Experience in managing Influencer campaigns on Social Media platforms like Tik Tok, YouTube shorts and Meta.</li><li>Industry Experience: Experience in OTC healthcare, consumer goods, or consumer services is required.</li><li>Strong experience working closely with advertising agencies.</li><li>Self-Motivated &amp; Independent: Ability to manage projects independently and deliver results with minimal supervision.</li><li>Strong Communication Skills: Excellent written and verbal communication skills, with the ability to engage and collaborate with both internal teams and external partners.</li></ul> Why Join Us: <ul><li>Growth Opportunity: Be a part of a rapidly expanding company with a strong entrepreneurial culture.</li><li>Flexibility: Enjoy a remote working environment.</li><li>Impact: Play a crucial role in expanding the profile and reach of “Our client” and its brands in the US market. </li><li>If you are a motivated, strategic thinker with a passion for consumer marketing and sales, we invite you to apply and join our dynamic team at our client.</li></ul>

Responsibilities: Design &amp; Development: <ul><li>Lead the design and development of drug combination products by understanding design space and managing critical design parameters.</li><li>Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&amp;T) to create sound engineering drawings.</li><li>Identify the best tools and approaches to effectively solve engineering problems.</li><li>Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.</li></ul> Technical Support &amp; Compliance: <ul><li>Support the evaluation and assessment of new technologies, intellectual property, products, and processes.</li><li>Provide support for existing products in terms of quality, manufacturing, and cost improvement.</li><li>Execute technical and cross-functional project work to ensure successful product development.</li><li>Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.</li><li>Collaborate effectively with laboratory technicians and support staff.</li><li>Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.</li></ul> Requirements: Regulatory &amp; Validation Expertise: <ul><li>Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).</li><li>Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3</li></ul> Experience: <ul><li>Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.</li><li>Strong understanding of disciplined product development processes and quality requirements.</li><li>Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.</li><li>Proficiency in SolidWorks is required.</li></ul> Skills &amp; Competencies: <ul><li>Strong interpersonal skills with the ability to collaborate effectively.</li><li>Excellent technical judgment and problem-solving abilities.</li><li>Demonstrated accountability for the successful completion of assigned tasks.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Material/Product Review &amp; Release:</li><li>Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.&nbsp;&nbsp;</li><li>Determine the acceptability of materials/products for release based on compliance with specifications and testing results.&nbsp;&nbsp;</li><li>Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.&nbsp;&nbsp;</li><li>Prioritize raw material review and release based on production scheduling requirements.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Minimum 5-12 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.&nbsp;&nbsp;</li><li>Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.&nbsp;&nbsp;</li><li>Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.&nbsp;&nbsp;</li><li>Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.&nbsp;&nbsp;</li></ul>

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28 pharma therapy Jobs found

Systems Engineer

HR Transaction Delivery Analyst

Medical Affairs Lead

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Digital Marketing Specialist

Staff Engineer – Devices

Quality Control Supervisor

Analytical Quality Assurance Specialist

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.