Design, validate, and maintain AMPS recipes and Electronic Batch Records (EBR); support and train end users; troubleshoot AMPS/SAP/MLM interfaces; create BOMs and production versions in SAP; track documentation, change controls, CAPAs, and audits; ensure cGMP/GDP compliance and smooth shop-floor operations.
Operation:
- To Design and simulate AMPS (Agile manufacturing production system) recipe towards ease of user execution and ensuring its feasibility as per site requirements.
- Ensuring recipe readiness per weekly manufacturing plan.
- Preparation/revision of Electronic Batch Records (EBR) based on the approved MMR/MBR/Validated Documents.
- Supporting end users on EBR execution/usage.
- Troubleshoot and solve AMPS/SAP/MLM problems and get in depth/detailed understanding/identify root cause.
- To proactively handle activities in Implementation projects and enhancements.
- Tracking all documentation activity, i.e., SOP revision, CAPA closure, change controls, change action items and investigation.
- Be the first point of contact for electronic manufacturing issues.
- Escalation of Electronic manufacturing execution issues to Shift Manager-MES or supporting teams.
- Having thorough knowledge of Manufacturing execution system (MES).
- Conducting training to executing personnel on EBR system.
- Handling of Shop floor troubleshooting in SAP- AMPS interface.
- Tracking of AMPS (Agile manufacturing production system) recipes revision as per revised/new batch records.
- Creation of Bill of Material (BOM) and production version (PV) in SAP.
- Ensuring readiness of Bill of Material (BOM) and production version (PV) in SAP required to create AMPS recipes.
- Handling of SAP (System Application and Products) related issues and shop floor support.
- SAP stock clearance, IDOC message clearance.
- BT ticket follow ups and ensuring its resolution with batch release tracking.
- To participate and execution of new upcoming MES projects.
- Handling/Designing and to ensure smooth running of Manufacturing label management (MLM) system.
- Coordinate supporting functional departments for smooth operation of production activities.
- Ensure all the activities performed comply with respective procedures.
- Ensure all the completeness of documentation for all performed activities.
- Review of all related protocols.
- Initiating change controls related to documents and equipment. Ensuring their closure and implementation of changes within specific time.
- Identify deviations/exceptions and escalate to reporting manager by appropriate procedures.
- Adherence to safety procedure/GMP & GDP practices.
Quality Management and Compliance:
- Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity.
- To participate in internal & external (regulatory & non-Regulatory) audits.
- To prepare the procedures, pertaining to area in compliances with regulatory requirements. Co-operate guidelines/practices.
- Ensure to fill/ write the documents pertaining to the respective area of work of work on line as per cGMP and GDP and submit the documents to the documentation cell on time.
- To prepare the daily activity report.
Training:
- To attend the training of all applicable procedures as per schedule.
- Training the team on relevant procedures and getting trained on respective area of work.
- To provide AMPS/SAP/ MLM training to new hires and refresher training to end users
Preferred Education/ Qualification:
Diploma/Graduate or Postgraduate in Pharmaceutical Science Discipline/Engineering
Experience:
0-3+ years of experience in manufacturing pharmaceutical dosage forms, in manufacturing operations
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and ControlPfizer Chennai, Tamil Nadu, IND Office
Chennai, India
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead sterile pharma/biopharma manufacturing teams to manage projects, improve processes, ensure cGMP/regulatory compliance, develop/operators, implement Lean tools, and drive performance and training.
Top Skills:
CgmpChatgptDownstream ProcessingLean ToolsMicrosoft CopilotUpstream Processing
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Territory-focused pharmaceutical sales role responsible for achieving sales budgets, developing and executing sales plans, conducting sales analytics, managing relationships with doctors, hospitals, chemists and KOLs, coordinating promotions and inventory, reporting daily activities, forwarding adverse events per SOPs, mentoring trainees, and ensuring compliance with Pfizer policies.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead and execute equipment, facility, utility and computer system validation activities. Review and approve validation master plans, protocols, and reports; troubleshoot validation issues; perform statistical and data analysis for investigations; manage change control and quality systems; support audits, product transfers, cleaning validation, and continuous improvement; coordinate cross-functional validation testing and maintain the site validation master plan.
Top Skills:
ChatgptComputer System Validation (Csv)ExcelGampGlobal Document Management SystemMicrosoft CopilotQuality Tracking SystemSAP
What you need to know about the Chennai Tech Scene
To locals, it's no secret that South India is leading the charge in big data infrastructure. While the environmental impact of data centers has long been a concern, emerging hubs like Chennai are favored by companies seeking ready access to renewable energy resources, which provide more sustainable and cost-effective solutions. As a result, Chennai, along with neighboring Bengaluru and Hyderabad, is poised for significant growth, with a projected 65 percent increase in data center capacity over the next decade.
