284 Cgmp Jobs - Page 7

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreements with external partners Risk assessments and periodic performance reviews of critical vendors Handling of audit observations and CAPA follow-up Supporting change control and deviation management related to vendors Qualifications B.Pharm / M.Pharm / M.Sc. in a relevant discipline 5-8 years of relevant experience in Quality Assurance, specifically in Vendor Management Sound knowledge of GMP regulations (USFDA, EU, MHRA, etc.) Experience in vendor audits and supplier qualification Strong documentation, communication, and interpersonal skills Proficiency in QMS tools and audit management systems

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparation & Review of Quality Assurance SOPs. 9) Review other Department SOPs. 10) Review of Executed BMR/BPR. 11) Participation in investigation of failures. 12) Participation in aseptic process simulation, cleaning validation and review of related documents and visual observations of Media fill vials. 13) In-process Quality Assurance during production activity and sampling at different stages of processing / packing as per requirement. 14) Monitoring and review of Quality system documents such as Deviation, Change control, OOS, OOT and CAPA. 15) Review of Master documents such as e-BPR, filter validation documents. 16) Review of stability study protocol and stability study reports Work Experience 5-6 years Education Graduation in Pharmacy Competencies

Role & responsibilities 1. Work closely with the Quality Assurance (QA) team to promptly address and resolve any deviations, non-conformances, or regulatory issues to maintain high-quality standards. 2. Manage and handle key QMS tools such as Change Control, Deviation Investigations, OOS (Out of Specification), OOT (Out of Trend), CAPA (Corrective and Preventive Actions), ensuring their timely closure. 3. Conduct thorough investigations for deviations, incidents, and market complaints to determine root causes and implement corrective actions. 4. Develop, implement, and enforce standardized operating procedures (SOPs) across all production departments to maintain consistency and quality standards. 5. Lead investigations and prepare detailed reports for deviations, OOS, OOT, CAPA, and other quality-related issues, ensuring clear documentation and resolution.

: - Excellent knowledge of products Manufacturing of Colour Cosmetics personal care, Skincare, Cream, Shampoo, Hair Oil, Conditioner, Face Wash, Body Wash, Body Lotion and Foot Care ,Lipstick, Nail Polish Etc. Lay down procedure to implement GMP & GLP norms and ensure documentation & compliance Define AQL for incoming raw material and components Develop vendor base to meet cost, quality (manufacturing and product), and innovation requirements Development of new formulation as per the business demand Preparation of documents & Registration of product, label compliance with regulatory authorities - local & overseas. Skills :- Must come from the personal care background. Worked for the majority of their career in the development of formulations for personal care products. Familiar with cosmetics compliance requirements for EU, US FDA. Ready and able to work on multiple product formulations at the same time, with a view to develop potentially new products.

Must have demonstrated experience and a track record of success as Cutover Manager / Lead on ERP transformations. Demonstrated through At least five years prior experience in having led SAP cutovers. Must have enterprise scale experience Develop and own the overall Deployment workplan. This should contain a list of deliverables and activities that will be executed by the Deployment workstream. Liaise with project teams to develop a detailed integrated cutover which include both technical and functional steps to be executed during the deployment phase. Identify risks, cross application dependencies and downstream impacts for each release. Manges risks and issues associated with the cutover and prepare appropriate mitigation plans Create and maintain a detailed Integrated Cutover Project Plan from inception, execution, and post-implementation. Determine go-live readiness criteria, socialize them with key stakeholders and obtain requisite approvals Plan and execute mock cutovers to help teams prepare for the final production cutover Responsible for ensuring successful planning and execution of integrated release cutover activities and associated systems' outages Leads cutover activities for Pre Go-Live, Go-Live and Post Go-Live Coordinates requirements for Go Live Monitor data and cutover progress and communicate to leadership team including status, progress. Manage the scope and schedule of cutover activities Provide detailed backout options for severe contingencies Ensure compliance with IT processes including proper documentation and securing approvals of requisite changes through our Change Advisory Board process Provide timely escalation to IT leadership where necessary. Liaise with the functional SAP experts and business teams in order to assist with the planning and execution of Deployment activities. Plans the resources, human and physical required for cut-over activities. Develops the communication and escalation plan. (policies, procedures, downtime processes etc Provides Cutover status reporting to the project leadership and key stakeholders. Ensures entry into and exit out of cutover stage gates are met including the final Go/No-Go meetings. Acts as the final point of escalation for all Cut-over issues, proactively bringing about appropriate interventions when the Cutovermay be jeopardized. Please Share below details and Updated Resume: MatchedYes/No:Full Name with Surname:DOB:Adhacard No(Mandatory):Alternate Contact Number:Total Experience:Relevant Experience:Current Location:Preferred Location:Current CTC :Expected CTC :Current Organization/ Contract with Current Org :Payroll Company:Notice period :Passport/ Expiry Date:Holding any offerYES/NO:

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Job Overview Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. Key Stakeholders: Internal Production , Supply Chain, Finance, Warehouse, operation excellence ,HR/QA, QC & Validation. Key Stakeholders: External Govt Departments, Regulatory Agencies, Suppliers, Vendors Reporting Structure Global Engineering Head & Project Head & Site Head Reportees :All Plant Engineering & Maintenance team Experience 20 years in a Pharmaceutical API Facility Competencies Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety. Responsibilities Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management: Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety: Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management: Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination: Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation: Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Qualifications Bachelors degree in Engineering (Mechanical, Electrical, or related field)

Role & responsibilities The position is responsible for Moisture and Thiomersal estimation and ensuring GMP practices Physical observation of vaccines and diluents Formulation Verification Record maintenance Maintenance of Live and Inactivated FG samples and register Maintenance of Pullet ND samples at R&D in coordination with production Moisture estimation of Live vaccines, stability & record keeping and R&D testing To Fill records & BTR Regarding Moisture Determination RM - pH, viscosity, density, specific gravity, refractive index, LOD, water Egg sampling and record maintenance Maintenance of retain samples of RM Preferred candidate profile Should have technical knowledge in GMP, GLP, ISO, IS, IP, BP guidelines, MS office Good in communication, inter-personal relationships Job Location: Kadi,Gujarat ( Bus facility available from Ahmedbad,Kalol & Kadi)

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behaviour / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Preparation to comply statutory audit, customer audit and regulatory audit. Batch charging and process work out as per written instruction. Shift handover / instruction/ information communication. Operation & cleaning of Equipments. Suggests changes in working conditions and use of equipment to increase efficiency of equipment. Initiates or suggests plans to motivate workers to achieve work goals. Maintaining cleanliness and hygienic practices in the plant premises.

Key Responsibilities: Perform analytical testing and analysis of raw materials, intermediates, and finished pharmaceutical products. Conduct instrumental and wet chemistry techniques, including HPLC, GC, UV-Vis, FTIR, and titrations. Develop and validate analytical methods for new and existing pharmaceutical formulations. Conduct stability studies and ensure proper documentation of results. Maintain and calibrate laboratory instruments and equipment. Prepare and review standard operating procedures (SOPs) for analytical testing and instrument operation. Ensure compliance with cGMP (current Good Manufacturing Practices), ICH guidelines, and other relevant regulatory standards. Support analytical troubleshooting and provide solutions for any issues that arise during testing. Review and interpret data, providing detailed reports and documentation for regulatory submissions. Collaborate with cross-functional teams, including R&D, production, and regulatory affairs. Conduct investigations and root cause analysis in case of product quality deviations. Maintain accurate records of all laboratory activities and ensure data integrity. Stay updated with new analytical techniques, instruments, and industry trends.

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Location- Novo Nordisk Global Business Services (GBS), Ahmedabad, India Department- GCM Operations Drug Product Are you ready to take charge and make a difference in the pharmaceutical industryIf you’re a dynamic person with a passion for quality and operational efficiency, you might be our new Operations Manager. The position is based in Ahmedabad in India and will report directly to GCM organization based in Denmark. Apply today and get life changing career! Apply now! The position As an Operations Manager, you will be responsible for ensuring Novo Nordisk’s interests with regards to short to midterm capacity, compliance, quality, manufacturing readiness and activities at the CMO. You will have a substantial impact on the business with the CMO with regards to strategy input, prioritization and following up on agreed actions and improvements. Your other responsibilities will be to: Responsible for short to midterm capacity, compliance, quality, manufacturing readiness and activities at selected CMOs ensuring timely delivery of products to downstream customers with a strong focus on production performance and quality. Developing and following up on joint KPI’s and creating a robust working relation with the CMOs. Identify and implement changes and process improvements at CMOs in order to create a strong and solid foundation for future growth in this area. Develop new work standards and setups for collaboration between GCM DP and relevant CMO’s delivering aseptic manufacturing activities. Participate in project work to the extent needed to ensure new projects/CMOs enter operations in a satisfactory manner. Approximately 3–5 weeks of travel per year is expected as part of this role. Qualifications To be successful in this role, you should have: Master’s or Bachelor’s degree in Engineering, Pharmacy, or a Supply Chain-related field, with excellent written and verbal communication skills and a strong command of English 10 years of experience within pharmaceutical manufacturing / packaging and cGMP and 5 years of experience with outsourcing or managing global CMOs. Experience in Production, Manufacturing Operations, Project management or Supply Chain management. Experienced in handling Changes, Deviations, and Customer Complaints, with strong knowledge of regulatory guidelines in the pharmaceutical industry, excellent relationship management skills, and a solid understanding of GxP principles. Team player demonstrating collaborative behavior, effective communicator providing clear and timely information to stakeholders, with a technical, analytical, and structured approach to problem-solving. About the Department Global Contract Manufacturing Drug Products (GCM DP) oversees all aspects of commercial external production, including filling, assembly and packaging. We prioritize diversity, encourage empowerment, and pride ourselves with a varied workforce, comprising a range of professional profiles such as project managers, supply chain professionals, specialists and operation managers.

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.