Manager, Analytical Quality Assurance

Site Investigation Lead, Quality Assurance

Head of Commercial Operations

Manager Transport Solutions - Bulk Freight

Quality Control Supervisor

Technical Support Engineer

Responsibilities: Accountability AQA Management <ul><li>Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.</li><li>Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.</li><li>Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.</li><li>Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.</li><li>Collaborate with QC, QA, and R&amp;D departments to support method validations, transfers, and investigations.</li><li>Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.</li><li>Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.</li><li>Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.</li><li>Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.</li><li>Mentor, coach, and develop the AQA team to build a high-performing quality organization.</li></ul> Workload Management <ul><li>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></ul> SOPs <ul><li>Review/Approve 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></ul> Staff Development <ul><li>Evaluate potential candidates for QA, performance evaluation of direct reports.</li><li>Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field (master’s or Ph.D. preferred).</li><li>Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control.</li><li>Proven leadership or supervisory experience in a GMP-regulated environment.</li><li>Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills..</li></ul> Knowledge <ul><li>Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia.</li><li>Knowledge of pharmaceutical manufacturing processes and laboratory practices.</li><li>Familiarity with regulatory submission requirements (ANDA, NDA, etc.).</li><li>Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise).</li></ul> Skills &amp; Abilities <ul><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><li>Excellent analytical thinking and problem-solving skills.</li><li>Strong attention to detail with a commitment to quality and compliance.</li><li>Effective leadership, team management, and interpersonal communication.</li><li>Ability to prioritize and manage multiple tasks in a fast-paced environment.</li><li>Proficient in technical writing and reviewing complex data and reports.</li></ul> Physical Requirements <ul><li>Ability to sit or stand for extended periods.</li><li>Occasionally lift up to 25 pounds.</li><li>Use of personal protective equipment (PPE) as required in laboratory or production areas.</li><li>Ability to work in office, laboratory, and manufacturing settings as needed.</li><li>The work environment is representative of a group laboratory environment.</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</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></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <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>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities 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><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</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>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</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>

Key Responsibilities• Create an inquisitive culture within the operations team to promote situational awareness of bulk commodity movements, trends, corridors, potential clients and networks.&nbsp;• Manage the operations function and all related resources for single/multiple accounts.&nbsp;&nbsp;• Ensure sound customer relations are established and maintained.&nbsp;• Oversee the financial performance of the operation.&nbsp;&nbsp;• Maintain a safe working environment for all staff and visitors.&nbsp;• Manage and implement tactical and operational outcomes and responsibilities.&nbsp;• Projects (parcel orders) executed as per committed time frames.&nbsp;• Actively manage Subcontractor KPI’s to ensure service delivery standards are maintained.&nbsp;&nbsp;• Formulate operational plans for the operations team ensuring the BU’s attains its objectives.&nbsp;&nbsp;• Help develop and implement growth strategies for the business units.&nbsp;&nbsp;• Holding regular client performance reviews to align to the client’s strategies.&nbsp;&nbsp;• Establish and maintain customer centricity. Ensure this attitude and behaviour is instilled amongst the operations team.• Manage corporate governance compliance and SHEQ compliance together with the SHEQ Manager.&nbsp;&nbsp;• Talent management and succession planning to meet business and individual needs.&nbsp;&nbsp;• Drive transformation and skills development.&nbsp;&nbsp;• Creating and maintaining a climate and culture of high performance, this includes development and coaching.&nbsp;&nbsp;• Maintain preferential procurement spending targets.&nbsp;• Review reports and monitor performance while ensuring reports evolve with business changes and requirements.&nbsp;&nbsp;• Negotiate favorable rates to ensure business profitability and cost savings for the client.&nbsp;&nbsp;• Identify opportunities to take value proposition to the next level.&nbsp;&nbsp;• Translate strategy into action.&nbsp; Minimum Requirements• Honours Degree (NQF Level 8) • Up to 8 years of experience in a similar environment with at least 5 years operational leadership or specialist experience.&nbsp; COMPETENCIES • Adaptability • Resilience • Interpersonal skills • Problem solving and analysis • Oral communication • Written communication • Quality conscious • Customer service and orientation • Leadership • Planning and organizing • Decision making PERSONAL ATTRIBUTES • High work ethic. • Self-motivated and proactive. • Integrity and accountability. • Passion and Energy: Passionate about finding solutions, positive and “can do” attitude and attention to detail. • Recognition and respect: Professionalism, ability to build and maintain professional relationships. • Commitment and pride: Flexibility in approach and thinking, involvement and contribution to employer and industry.

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>

Overview:&nbsp; <ul><li>You shall be a part of the Technical Support Center (based out in Pune, India).</li><li>The Technical Support Center is a team of highly responsive technology specialists whose #1 focus is to</li><li>support/resolve the customers for Presales and Post Sales Technical issues while delivering the best</li><li>possible customer experience.&nbsp;</li><li>You can measure your success through excellent financial results, growing</li><li>customer happiness metrics, industry recognition, on time resolution and employee happiness scores.</li><li>You shall be the first point of contact for customers and partners all over Americas, EMEA &amp; APAC.</li><li>Youll have insight on the detailed functionality of products and partner with all distributed</li><li>elements of the service chain.</li></ul> Responsibilities: <ul><li>You will be responsible for creating and driving support tickets within the required SLA parameters.</li><li>will depend on you to provide the highest standard of customer support for Switching, routing</li><li>,security , Wireless, Cables &amp; Connectivity.</li><li>Remotely provide Presales as well as Post sales support making sure the customer is satisfied with the level of service provided. Manage the tech support day-to-day operations to achieve qualitative and quantitative targets at team/staff level and to maintain overall quality standards.</li><li>You shall be responsible for achieving all metrics for the respective customer/partner, as defined by the management with particular focus on customer satisfaction. </li><li>Gather the required information necessary to best handle customer software and technical inquiries.</li><li>Resolving the issues through Phone, chat and ticketing tool - communication channels.&nbsp;</li><li>Collaborate with Technical Support team members to properly manage customer queries and escalate when appropriate.</li><li>Document solutions for knowledgebase.</li><li>Work to support customer technical issues encompassing hardware, software, and networking.&nbsp;</li><li>Create knowledge base articles on products.</li><li>Connect with wide range of people and teams to find these solutions such as Solution Consultants,Product Line Managers, and the various plants.</li><li>Provide technical service for products and solutions in India and deliver professionally and</li><li>disciplinarily.</li><li>Deliver end to end solution as per customer demand.</li><li>Assist customers with Support Requests and engaging with other Teams ensuring follow up on each request and solution is provided.</li><li>Continuous improvement of their professional certification level.</li></ul> Requirements : <ul><li>Bachelor’s degree in Telecom, Computer Science, Electrical Engineering/Electronics/ IT.</li><li>CCNA Certified. Hirschmann switches, router and security devices knowledge would be added</li><li>advantage.</li><li>Minimum 3-10 years working experience.</li><li>2~3 year’s implementation experience in Managed and unmanaged switches, Internet wireless LAN,</li><li>Industrial Security Systems, Embedded Ethernet modules, Fiber optic field bus repeaters, Secure</li><li>remote access, Network Management Software, Industrial Connectors, industrial network security</li><li>products for process control, SCADA manufacturing and automation sectors.</li><li>Experience in customer support, service or after sales in networking system will be added advantage.</li><li>Understanding of networking protocols.</li><li>Knowledge of transmission technology, OTN and Network Access control would be a plus.</li><li>Hands-on experience with monitoring, network diagnostic and network analytics tools/network</li><li>configuration experience with Cisco etc.</li><li>Ability to quickly learn new or unfamiliar technology and products using documentation and internetresources.</li><li>Basic Level of understanding of Routing and Switching, Basic Data networking, including DHCP, RSTP, VLAN, QoS, IGMP, network redundancy, IP routing protocols and standard VPN technology.</li><li>Industrial networking and IIoT/IoT digitalization knowledge would be added advantage.</li><li>Good English in reading and written, and good oral English is a must.</li><li>Ability to multitask in a fast-paced environment.</li></ul>

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Manager, Analytical Quality Assurance

Site Investigation Lead, Quality Assurance

Head of Commercial Operations

Manager Transport Solutions - Bulk Freight

Quality Control Supervisor

Technical Support Engineer

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6 pattern recognition Jobs found

Manager, Analytical Quality Assurance

Site Investigation Lead, Quality Assurance

Head of Commercial Operations

Manager Transport Solutions - Bulk Freight

Quality Control Supervisor

Technical Support Engineer

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

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