Inspection Technician

Quality Associate I

QE Specialist

Quality Engineer

Head of Sales and Marketing Nutraceuticals

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

Manager, Operations

Life Sciences Sales Engineer

Product Manager & Business Development Manager (Pharma)

Operations Supervisor

Role Description: <ul><li>Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.</li><li>The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</li><li>This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.</li></ul> Responsibilities: <ul><li>Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.</li><li>Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform visual inspection of final product to ensure conformance with quality standards and specifications.</li><li>Perform AQL testing manually to verify integrity of the automated inspection system.</li><li>Serve as first-line troubleshooting support for equipment and GMP manufacturing issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to other production personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications/Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of product post fill inspection.</li><li>Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.</li><li>Knowledge of cGMP, and aseptic processing, requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Precise skills for inspecting finished product effectively.</li><li>Demonstrated problem-solving and troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>Comfortable working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills / Competencies <ul><li>Strong knowledge of 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: Strategic &amp; Commercial Leadership: <ul><li>Develop and execute the commercial strategy to drive growth across product categories (e.g., vitamins, functional foods, probiotics, and herbal supplements).</li><li>Formulate annual business plans, budgets (A&amp;P and Trade Spend), and sales forecasts, and actively manage the P&amp;L to drive top-line revenue, gross margin improvement, and profitability.</li><li>Identify new business opportunities, strategic partnerships, and channel expansions (modern trade, e-commerce, pharmacy, and healthcare professionals).</li></ul> Market Access and Sales Management: <ul><li>Lead and oversee national sales operations, including regional sales teams, distributors, and key accounts.</li><li>Establish strong relationships and negotiate favourable long-term trade terms and contracts with key national and regional accounts.</li><li>Drive customer and channel engagement initiatives to strengthen brand presence and relationships.</li><li>Manage pricing strategies, trade terms, and promotional budgets in line with profitability goals.</li><li>Establish clear performance metrics (KPIs) and monitor sales productivity, market coverage, and territory growth across all channels.</li></ul> Marketing &amp; Brand Development: <ul><li>Develop and implement marketing strategies and campaigns to position the company as a credible and trusted nutraceutical brand in Indonesia.</li><li>Oversee product launches, lifecycle management, and portfolio strategy.</li><li>Conduct market analysis, consumer insights, and competitive intelligence to guide decision-making.</li><li>Collaborate with R&amp;D and Regulatory teams to ensure all product claims and marketing materials are fully compliant with local regulations.</li><li>Lead digital marketing, e-commerce, and omnichannel initiatives to strengthen consumer engagement and off-take</li></ul> Cross-functional Collaboration: <ul><li>Partner with Supply Chain, Finance, Regulatory, and Medical Affairs for seamless go-to-market execution.</li><li>Align with corporate and regional teams on strategic direction and brand consistency.</li><li>Support accurate forecasting, demand planning, and inventory control to ensure market availability.</li></ul> People Leadership: <ul><li>Build, lead and develop high-performing sales and marketing teams.</li><li>Set clear performance goals, monitor performance, and implement training and capability development programs.</li><li>Foster a culture of collaboration, accountability, and ethical business practices.</li></ul> Key Performance Indicators (KPIs): <ul><li>Achievement of sales revenue, margin, and market share targets.</li><li>Growth in distribution and channel penetration.</li><li>Success of new product launches and marketing campaigns.</li><li>Customer satisfaction and brand awareness.</li><li>Employee engagement and retention within the commercial team.</li></ul> Core Competencies: <ul><li>Strategic &amp; Commercial Acumen: Expertise in P&amp;L management and developing scalable commercial strategies.</li><li>Brand Building &amp; Positioning: Ability to build brand equity and differentiate products in a competitive health market.</li><li>Channel &amp; Customer Management: Mastery of Indonesian trade structures and key account negotiation.</li><li>Analytical &amp; Data-Driven Decision Making: Proficiency in utilizing market data for investment optimization.</li><li>Leadership &amp; People Development: Proven ability to build, inspire, and develop a high-performing commercial team.</li><li>Innovation &amp; Market Insight: Deep knowledge of nutraceutical trends, consumer behaviour, and product innovation cycles</li></ul> Requirements: <ul><li>Education: - Bachelor’s or master’s degree in business, Pharmacy, Nutrition, or Life Science</li><li>10–15 years of experience in Sales and Marketing, preferably in Nutraceuticals, FMCG Health, or Consumer Healthcare.</li><li>Proven leadership in managing commercial teams.</li><li>Experienced in driving new launches or significant expansion of a new portfolio or business unit within a structured corporate environment.</li><li>Strong understanding of nutraceutical market trends, regulatory frameworks, and consumer behaviours.</li><li>Excellent leadership, negotiation, and strategic planning skills.</li><li>Fluency in both English and Bahasa Indonesian is required.</li></ul>

Responsibilities: Regulatory Support: Innovation:&nbsp; <ul><li>Work closely with R&amp;D and business partners regarding regulatory matters.&nbsp;</li><li>Work closely with Product development, marketing, legal and all relevant teams to ensure local regulatory and external requirements, restrictions and risks are identified, accurate, relevant and timely input given to innovation projects. (These could be in areas of claims, labelling, permitted additives/formulations, new product regulations.)</li><li>Performs regulatory compliance assessments for the markets of scope.</li><li>Performs technical registrations across markets of scope through preparing registration files and applying at the government bodies responsible for registration.</li></ul> Advocacy: <ul><li>Understands external environment and regulatory developments, supports building lobbying plans, advocacy priorities and actions aligned with relevant interfaces (legal, R&amp;D.)</li><li>Provides RA input on the topic and helps to implement the communication plan with other functions locally.</li><li>Implement advocacy plans for regulatory changes or new product regulations.</li><li>Represent the function in external platforms on technical issues, lobby activities and approvals to support aligned and agreed lobby/advocacy topics.</li></ul> Wellbeing Support: <ul><li>Propose / calculate the nutrition facts of recipes/breakfasts/snacks with our products, comparison with other traditional options.</li><li>Assist in compliance with nutrition regulations and self-governance, localization of substantiation for claims (TV, print, web, POS).</li><li>Management of a nutrition database of products in the region, populating it with renovations and innovations</li></ul> Requirements: <ul><li>A Scientific degree (Pharmacy, Science.), a nutrition degree is a plus.</li><li>Should have a minimum of 1-3 years of experience in Regulatory Affairs/Nutrition Function in a Food Industry.</li><li>Ability to be a team player in support of the team and the business.</li><li>Ability to organize and coordinate</li><li>Ability to work in a high-pressure environment with tight deadlines</li><li>Analytical thinking with the ability to plan, prioritize and deliver results&nbsp;</li><li>Knowledge of the health agenda in food and nutrition and awareness of key players in the Reg and wellbeing debate&nbsp;</li><li>Commercial interest with the ability to demonstrate a committed approach to delivering for the customer and consumer.</li><li>A confident communicator capable of presenting.</li><li>Good Language Skills / Vocabulary in written and spoken English and preparation of Techno legal drafts.</li><li>Any other languages like French is a good to have.</li></ul> Work Environment: <ul><li>Based in Cairo.</li><li>Internal Relationship: Legal, Marketing, supply chain, Corporate Affairs, R&amp;D.</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><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></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><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></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: <ul><li>Maintain contact with customers and ensure company products are specified.&nbsp;</li><li>Achieve or exceed sales targets.&nbsp;</li><li>Identify design consultants and engineering contractors involved in projects with close and regular contact making us their preferred pump choice.</li><li>Identify upcoming projects and that the company specification is used.</li><li>Keep Southeast Asia teams updated on projects by discussion and to maintain and progress projects.&nbsp;</li><li>Arrange and run customer training and presentations, which can be on-site and/or office based</li><li>Feed back potential product improvements and complaints, where new applications offer greater potential but existing specifications exclude or lessen our suitability.</li><li>Increasing our market share by replacing other pump types as well as other manufacturers peristaltic pumps.</li><li>Keep the Sales Manager updated with competitor activity encountered in the market place.</li><li>Identify, organise and progress field trials.&nbsp;</li><li>Identify and lead marketing activities maintaining our brand and find new opportunities.</li><li>Keep CRM up to date with all customer activities.</li><li>Conduct all activities in accordance with the Quality Management System</li><li>To regularly attend selected exhibitions and provide necessary market reports/ trends&nbsp;</li></ul> ﻿Requirements: <ul><li>Able to lead, communicate and foster relationships with customers and colleagues</li><li>Fault finding and problem solving skills</li><li>Prioritizing workload</li><li>Working in a largely unsupervised manner</li><li>Working within procedural guidelines in a methodical manner&nbsp;</li><li>Formal relevant engineering qualifications or strong business background</li><li>Process Engineer in Biopharmaceutical/Pharmaceutical company; and/or educational background of Medicine, Pharmacy, Biomedical or any related Bio related courses will be an added advantage</li><li>Experience in Fluid Handling industry (Pumps)&nbsp;</li><li>Proficient in both English writing and reading competencies</li></ul>

Responsibilities: Marketing Planning (40%): <ul><li>Strategic planning and leadership to drive brand performance in ensuring successful market penetration (Prelaunch preparedness and go to market strategies)</li><li>Develop programs to maximize field selling efforts such as sample strategy, sales meetings, and all sales force related marketing activities.</li><li>Development of the annual brand business and budget plan, strategy &amp; objectives</li><li>Develop and plan resource allocation effectively to address changing market dynamic and competitions</li></ul> New portfolio exploration and business development (35%): <ul><li>Conduct market insights for new product (market data analysis, gather insights from HCPs)</li><li>Develop patient flow and product forecast based on the portfolio analysed</li><li>Build business case for the new portfolio encompassing the pharma range (prescription drug), medical devices and consumer health</li></ul> Marketing Implementation (25%): <ul><li>Formulate, direct and coordinate all customer segment marketing activities and tactics to launch and promote the brand, working with agencies and cross functional partners.</li><li>Create and enhance relationships, internal and external, that contribute towards establishing the brand (key customers, thought leaders, associations and industry players) and implement establish KOL strategy&nbsp;</li><li>Manage brand budget efficiently</li><li>Timely development of promotional program/ materials that enables effective delivery of marketing messages</li><li>Support CMEs &amp; conduct product trainings to field-force</li></ul> Requirements: <ul><li>Bachelor’s Degree in Science. Proficient in English.&nbsp;&nbsp;</li><li>Minimum 2-3 years of relevant experience in marketing.&nbsp;</li><li>Has knowledge in these key healthcare channels: GP, private hospital, public hospital and retail pharmacy&nbsp;</li><li>Customer focused with strong interpersonal skills and able to illustrate agility to work and manage cross-functional teams.&nbsp;</li><li>Able to demonstrate new pilots in the areas of digital and analytics</li><li>Detail oriented and having the ability to actively listen.</li><li>Solid communication skills including presentation, verbal and written abilities. Shortlisted candidates are required to do a business case project.&nbsp;</li><li>Strategically focused, results oriented with strong problem-solving skills</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>

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12 pharmacy Jobs found

Inspection Technician

Quality Associate I

QE Specialist

Quality Engineer

Head of Sales and Marketing Nutraceuticals

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

Manager, Operations

Life Sciences Sales Engineer

Product Manager & Business Development Manager (Pharma)

Operations Supervisor

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12 pharmacy Jobs found

Inspection Technician

Quality Associate I

QE Specialist

Quality Engineer

Head of Sales and Marketing Nutraceuticals

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

Manager, Operations

Life Sciences Sales Engineer

Product Manager & Business Development Manager (Pharma)

Operations Supervisor

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