1756 Gmp Jobs - Page 18

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: The Quality Assurance Associate Director will support a technical team interfacing between our Company and External Partners in the Biologics Drug Substance and Drug product manufacturing area. This individual will be responsible for ensuring that all quality assurance processes, and compliance requirements are met during technical transfers to and from External Partners and throughout the continuous commercial manufacturing process at External Partner sites. Key Responsibilities: Quality Oversight: Report to the Quality lead (or delegate) and provide general direction on quality goals and objectives, functioning independently to ensure oversight of all quality-related issues at External Partner site. Regulatory Compliance: Ensure that all quality assurance activities comply with regulatory requirements (FDA, EMA, etc.) and internal quality standards throughout the product lifecycle, including during facility start-up and technical transfers. Manufacturing Support: Provide ongoing quality support to External Partners by resolving quality issues, performing proactive analysis of process performance, and developing plans to ensure compliance and quality meet capacity needs. Collaboration: Work collaboratively with Biologics Quality Operations and other relevant teams within the Focused Factory to support the product lifecycle and address quality-related matters. Validation Strategies: Support and oversee validation strategies for new and existing products, ensuring compliance with best practices in quality assurance. Technical Review: Conduct a calibrated technical review of External Partners process change requests, deviations, protocols, and Master Batch Record changes to ensure compliance with quality standards. Issue Resolution: Troubleshoot quality-related manufacturing issues and support investigations using scientific problem-solving methodologies. Efficiency Improvement: Work with Operations, Quality, and External Partners to develop more efficient methods to meet regulatory requirements while ensuring quality standards are upheld. Quality Management System: Ensure adherence to the highest quality, compliance, and safety standards by participating in and complying with our Manufacturing Division Quality Management System requirements. Partner Engagement: Collaborate with External Partners to achieve business goals while fostering a common culture that prioritizes quality and compliance for both organizations. Education Minimum Requirement: Bachelor s or master s degree (or equivalent) in Chemical/Biochemical Engineering, Biotechnology, Microbiology, Pharmaceutical Science, Life Sciences, or a related field. Required Experience and Skills: Proven experience in highly regulated manufacturing environments with a minimum of 15 years of experience in quality assurance within biopharmaceutical operations, particularly related to Drug substance and drug product manufacturing and validations. Strong knowledge of quality systems, regulatory compliance, and quality assurance practices in the biopharmaceutical industry. Familiarity with change management processes and regulatory support planning. Experience in process validations, cleaning validations, and the associated quality documentation requirements. Proficiency in large molecule manufacturing, in process controls, analytical testing, validations, batch records review and release. Ability to perform risk assessments and develop strategies for continuous improvement initiatives. Proficient in computer system validations, equipment validations, area qualification, Audits, batch release procedures. Effective communication skills for managing partnerships and addressing quality concerns. Preferred Experience and Skills: Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality. Experience with quality management software and metrics analysis to drive performance improvements. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Adaptability, Biotechnology, Change Management, Cross-Cultural Awareness, Cross-Functional Teamwork, Digital Manufacturing, GMP Training, Good Distribution Practice (GDP), Immunochemistry, Inspection Readiness, IS Audit, Management Process, Manufacturing Compliance, Manufacturing Environments, Manufacturing Quality Control, Microbiology, Product Lifecycle, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Metrics, Quality Standards, Quality Systems Compliance {+ 2 more} Preferred Skills: Job Posting End Date: 08/11/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Responsibilities: * Implement Change Control procedures during deviations/CAPAs. * Conduct BPR reviews, BMR analysis, GMP compliance checks. * Ensure product quality through process validation and CAPA implementation.

Product Owner - LIMS |10-16 Years| Hyderabad Product Owner - LIMS |10-16 Years| Hyderabad We are seeking a highly motivated and experienced Product Owner/Business Analyst/Subject Matter Expert to lead the development and enhancement of our Laboratory Information Management System (LIMS). This role will be responsible for defining and prioritizing product requirements, translating business needs into technical specifications, and ensuring the LIMS effectively supports our laboratory operations. The ideal candidate will possess a deep understanding of laboratory workflows, data management principles, and regulatory requirements within the [Specific Industry - e.g., Pharmaceutical, Biotech, Environmental Testing] industry. This is a hybrid role requiring a combination of product ownership, business analysis, and subject matter expertise. **Responsibilities:** * Define and maintain the product vision, strategy, and roadmap for the LIMS. * Prioritize and manage the product backlog, ensuring alignment with business goals and user needs. * Act as the primary point of contact for the LIMS product, representing the voice of the customer and stakeholders. * Collaborate with development teams to ensure successful product delivery. * Participate in sprint planning, daily stand-ups, sprint reviews, and retrospectives. * Translate business requirements into clear and concise user stories, acceptance criteria, and functional specifications. * Create process flows, use case diagrams, and other visual aids to communicate requirements effectively. * Conduct gap analysis to identify discrepancies between current and desired LIMS functionality. * Assist with user acceptance testing (UAT) and provide support to end-users * Serve as a subject matter expert on LIMS functionality, data management, and industry best practices. * Provide guidance and support to users on LIMS workflows and data entry procedures. * Stay up-to-date on industry trends and emerging technologies related to LIMS. * Participate in the evaluation and selection of new LIMS modules or enhancements. * Ensure the LIMS complies with relevant regulatory requirements, such as [e.g., FDA 21 CFR Part 11, GLP, GMP]. * Develop and deliver training materials and documentation for LIMS users. * Configure and customize the LIMS system to meet specific laboratory needs. 1. The Software Engineering Leader oversees and guides teams to deliver high-quality software solutions aligned with organizational goals and industry best practices.2. Is a professional in technology, proficient in strategic planning, decision-making, and mentoring, with an extensive background in software development and leadership.3. Is typically responsible for setting the strategic direction of software development efforts, managing project portfolios, and ensuring effective execution of software engineering initiatives to meet organizational objectives.4. Builds skills and expertise in leadership, staying abreast of industry trends, and cultivating a collaborative and high-performance culture within the software engineering team.5. Collaborates and acts as a team player with cross-functional teams, executives, and stakeholders, fostering a positive and productive environment for successful software development initiatives. - Grade Specific Skills (competencies) Verbal Communication

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Supplier Quality Specialist, Nutrition Job Details | Actylis Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Supplier Quality Specialist, Nutrition Ahmedabad, GJ, IN, 382110 Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you ll consider joining us! POSITION SUMMARY: The Supplier Quality Specialist (NUT) will be responsible for ensuring that all materials and products sourced from suppliers meet our stringent quality standards and regulatory requirements. This role involves close collaboration with cross-functional teams and suppliers to maintain and enhance our quality systems. Key Responsibilities: Supplier Qualification: Evaluate and qualify new suppliers and/or service providers through desktop audits, assessments, and performance reviews to ensure compliance with industry standards and regulatory requirements. Keep the Global Approved Supplier List up to date in MasterControl. Ensure that all supplier statements and certifications are current and uploaded into MasterControl. Audit Management: Plan and conduct regular supplier and/or service provider requalification desktop audits, as required. Coordinate with the Global Audit Team to ensure that on-site supplier qualification and/or requalification audits are planned and performed as per the established schedule. Ensure that all supplier CAPAs have been implemented and that audit reports are closed in the Audit module in MasterControl. Documentation and Reporting: Maintain accurate and comprehensive records of supplier qualifications, audits, and performance metrics. Prepare monthly reports around supplier qualification activities and present to management. Regulatory Compliance: Ensure that all supplier-related activities comply with relevant nutritional regulations, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Attend conferences and training to ensure industry knowledge is always current. Supplier Development: Collaborate with the Supplier Management Team and suppliers to develop and implement quality improvement plans, fostering strong, long-term partnerships. Risk Management: Identify and mitigate potential quality risks associated with supplier materials and processes. Qualifications & Experience: Bachelors degree in a relevant field such as Biology, Chemistry, or Engineering. Minimum of 5 years of experience in supplier quality assurance, preferably in Nutritional products being sold in the US and EU. In-depth knowledge of ISO/FSSC 22000, 21 CFR 117, EU directives & guidelines, HACCP and other relevant regulatory requirements. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Attention to detail. Self-starter. Proficiency in quality management systems and auditing techniques. SUPERVISORY RESPONSIBILITIES: N/A Actylis is an Equal Opportunity Employer. Actylis does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Key Accountabilities (2/6) Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (3/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Key Accountabilities (4/6) Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Title: Manufacturing Executive Work Level: 1B Work Location: Nashik Factory Roles and responsibilities: Production Management and Supervision Oversee daily production activities to ensure targets are met, monitoring machine operations and plant performance. Supervise shop-floor employees, union, and operators, coordinating with shift officers for smooth operations and addressing employee concerns. Ensure optimum utilization of resources and manpower. Maintain shift-wise reports on production, quality, and downtime, and review logs for machinery, maintenance, and RM, PM usage (tech-eff). Process Improvement and Efficiency Identify and implement process improvements and efficiency opportunities under UMS pillars Evaluate productivity, Overall Equipment Effectiveness (OEE), OPE, tech-eff to identify gaps and initiate improvement projects or kaizens. Review shop floor production wastage (RM, PM, SFG) and rework inventory to enhance material handling and technical efficiency. Quality Ensure adherence to quality standards (like GMP, HACCP, FSSAI, etc. ). Coordinate with the Quality team to resolve issues quickly and conduct in-process checks and inspections. Implement Quality Improvement Plans (QIP) at the site along with the quality executive. Stakeholder management-Projects & Supply Chain and Efficiency Coordinate with stakeholders such as R&D, CQA, SUIT & Planning, Engineering teams, FSSAI and suppliers to effectively manage and achieve overall business KPIs and comply to statutory requirements Execute the material savings initiatives & projects along with stakeholders. Execute short-term and long-term capacity projects at the site with stakeholders to meet volume commitments. Coordinate with the Engineering team to deliver plant reliability and capacity enhancement projects. Support the implementation of innovation and new product launches within the factory in collaboration with SUIT and R&D teams. Assist the Supply Chain team in resolving RM and PM supply issues by initiating strategic actions such as new vendor development and reviewing vendor performance. Identify opportunities for savings in production setup by improving efficiencies and securing finance team approvals for these projects. Digital Initiatives Engage in the deployment of the digital agenda for production setup by working on initiatives such as DFOS, Build app, and Auto-manning. Safety and Environmental Programs Collaborate with the SHE team in planning and implementing safety and environmental programs and ensure nil incidents on shopfloor. Employee Engagement and Development Connect with blue-collar workers to address their wellbeing, enhance productivity, and facilitate upskilling opportunities. Optimize manpower and handle union-related matters effectively. Lead Kaizen and continuous improvement initiatives through employee engagement and encourage autonomous maintenance practices. Serve as a core team member in LTS discussions, leading initiatives alongside HR and Manufacturing Manager. Qualification: Instrumentation/Mechanical Engineer/Food Technology (Ice Cream) with a prior experience of working in a process plant or a food/Ice cream plant Experience: Minimum of 5 years Skills Required: MS Office-Excel, PPT (Must have), Power BI (Good to have)

JOB DESCRIPTION Job Title: Lead - Tech support (LIMS/ELN-QCM) Job Location: Bangalore About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role : Static data creator/ reviewer for LIMS Validation of LIMS and ELN sheet Thorough knowledge on LIMS development, validation and GMP modules Knowledge on guidelines requirement for microbial analysis Ensure Microbial Method Validation, Method verifications Planning Microbiology analysis (Bioburden, MLT, Test for specified organisms, BET analysis) Sterility testing and validation Calibrations, Qualifications in Microbiology lab Handling QMS in Microbiology lab Role Accountabilities Documents preparation/review/validation for LIMS and ELN for microbiology Facing regulatory and client audits, ensuring audit compliance Leading team for Microbial analysis section Ensuring Microbiology lab maintenance Media and culture qualifications data review and planning Responsible for Ensuring Microbiological analysis, Sterility testing, Bacterial Endotoxin Test and analysis of different grades of water (PW/WFI/POW) as per the respective specification. Responsible for risk assessment documents preparations, Protocol and reports preparation Responsible for QMS related to microbiology - change controls, CAPA, deviations, incidents, OOS/OOT investigations Responsible for Area qualification, calibrations, equipment qualifications and requalification Responsible for sample management and coordination with team for smooth operation of samples release activity. Responsible to perform the Method verification activity for Sterility, BET, MLT and Bioburden test. Responsible for review of microbiology documents Responsible for review of specifications and STP. Responsible for review of protocols and reports Preparation and planning of sampling schedule Interaction with clients Ready to work in shifts and supervising the shift analyst activities Follow the required EHSS policies and Good hygiene practice. Undertake other responsibilities related to Microbiology as per requirement. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience : Demonstrated Capability : Education : Experience : 9-10 yrs YEARS Skills and Capabilities Microbial analysis of water, OSD products, Injectable products, Environmental monitoring Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team Good speaking-listening-writing skills, attention to details, proactive self-starter Ability to work successfully in a dynamic, ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be able to work in team and flexible for working in shifts Should be a focused employee Good documentation capability Education : M. Sc. Microbiology Equal Opportunity Employer .

Position summary statement Lead in upholding Herbalifes quality standards at our India manufacturing site. Supervisory responsibilities As the Site QA Lead at the Contract Manufacturing (CM) facility in Himachal Pradesh for Herbalife ayurveda products. Monitoring processes at set frequencies to ensure compliance with Herbalife Quality procedure requirements. Conducting periodic audits of the facility and operations to help CM meet and improve quality and hygiene standards as per Herbalife Quality standards, Ministry of Ayush, Ayurveda product standards, and FSSAI GMP Guidelines. Communicating regularly with CM regarding any applicable changes in product processes impacting quality. Coordinating with CM for complaint handling, conducting Root Cause Analysis (RCA), and implementing Corrective Actions Preventive Actions (CAPA). Supporting CM in troubleshooting raw materials, packing materials, and process quality challenges, driving improvements to eliminate defects in Herbalife products. Conducting regular training sessions for the site team on updates in quality requirements and changes in quality procedures. Verifying documents and providing dispatch approvals for all batches from the site, ensuring no product is cleared for shipment without approval. Collating information for regular MIS and sharing periodic reports with the team based on defined requirements. Supporting site validation of new products to be manufactured. Participating in cross-functional improvement projects, meetings, and conferences as per defined responsibilities. Testing raw materials, packing materials, and finished goods, participating in Out-of-Specification (OOS) investigations. Leading continual improvement projects for quality assurance and control. Organizational relationships This position reports directly to the Manager QA India and involves significant collaboration with the site team and other cross-functional teams. Minimum qualifications Education Graduation or Post Graduation in Food Technology, Food Science, Chemical Technology, Pharma, or other allied streams. Skills Proven experience handling Ayurveda products with a robust knowledge of Ayush requirements. Experienced or trained in Quality and/or Food Safety Management System implementation (HACCP, ISO 9001, ISO 22K, FSSC 22k). Working knowledge of basic quality control processes such as calibration, OOS, OOT, sampling, and relevant test procedures. Proficiency in Microsoft Office (Word, PowerPoint, Excel). Excellent communication skills, both written and verbal. Experience Minimum 8-10 years of experience in a relevant field. Industry type: Ayurveda, Nutraceutical, Pharma, Food.

As a Scrum Master at Sanofi, you will be responsible for facilitating Agile practices and principles within the Digital Manufacturing team, focusing specifically on Manufacturing Execution System (MES) solutions. You will ensure efficient delivery of digital products that optimize manufacturing processes and align with our strategic objectives. This role sits within the Digital Product job family as identified in Sanofis Job Architecture. What you will be doing: The Digital Manufacturing team is responsible for implementing and maintaining digital solutions that enhance manufacturing operations across Sanofis production facilities. The MES solutions are critical systems that bridge the gap between enterprise planning systems and shop floor control systems, providing real-time monitoring, tracking, and documentation of the transformation of raw materials into finished products. As Scrum Master, you will play a key role in ensuring the successful implementation and continuous improvement of these systems through agile methodologies. Key Responsibilities Agile Process Facilitation : Lead Scrum ceremonies including sprint planning, daily stand-ups, sprint reviews, and retrospectives for MES implementation and enhancement projects Team Coaching : Coach cross-functional team members on Agile methodologies and help remove impediments to team progress Manufacturing Domain Support : Collaborate with manufacturing subject matter experts to ensure MES solutions meet operational requirements Continuous Improvement : Facilitate continuous improvement of team processes and practices in the context of manufacturing systems development Stakeholder Management : Collaborate with Product Owners, manufacturing leaders, and IT stakeholders to ensure alignment on priorities and deliverables Metrics & Reporting : Track and report on team velocity, sprint burndown, and other key performance indicators relevant to MES implementation Cross-functional Collaboration : Work closely with other Scrum Masters, Agile COE, manufacturing teams, and IT departments to share best practices and ensure system integration Coordination : Coordinate with the MES capability team in Hyderabad and other stakeholders to achieve/ appropriate/ align the planning and deliveries. Required Qualifications Degree in business administration, computer science, information sciences, or other related field; 5+ years of experience in Agile methodologies, scrum framework, project management or other related field Scrum Master certification (CSM, PSM, etc) Strong facilitation and coaching skills Excellent communication and interpersonal abilities Problem-solving mindset with ability to remove impediments Experience with Agile tools (Jira, Confluence, etc) Preferred Qualifications Experience in pharmaceutical or manufacturing industry Knowledge of Manufacturing Execution Systems (MES) or related manufacturing technologies Understanding of GMP (Good Manufacturing Practices) and pharmaceutical manufacturing processes Experience with scaled Agile frameworks (SAFe, LeSS, etc) Background in digital transformation projects within manufacturing environments Why Choose Us Opportunity to contribute to Sanofis digital manufacturing transformation journey Career development within our Digital, Data & Technology organization Collaborative and innovative work environment Ability to make a meaningful impact on healthcare outcomes through manufacturing excellence

Role & responsibilities 1. Daily balance verification before activity as per respective SOPs. 2. Operation, cleaning and troubleshooting of CDL machine, Converting machine, Cartonator, checkweigher, Track and Trace system and other Primary and secondary packing machines. 3. Timely check the in-process parameters, online entries in of BMR / BPR and online documentation. 4. To do the timely changeover of the parts in the machines as per process requirement and production planning. Preferred candidate profile Candidates should have exposure to Cartonator machine operation / Track & Trace, Check Weigher, Vision inspection System.

Technical Skill : Routine Operation & Analysis API Products HPLC, WET Lab Analysis

1.Routine Operation & Analysis API Products 2.HPLC, WET Lab Analysis