Operation
- To Design and simulate AMPS (Agile manufacturing production system /FTPS) 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 to get in depth/detailed understanding/identify root cause.
- To proactively handle activities in Implementation projects and enhancements.
- Tracking of 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 trainings 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 issue 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 performed activities 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, equipment. Ensuring their closure and implementation of changes within specific time.
- Identify deviations/exceptions and escalate to reporting manger 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.
ESSENTIAL REQUIREMENTS
Graduate or Postgraduate in Pharmaceutical Science Discipline/Engineering
Experience
6 to 10 year of experience in manufacturing of pharmaceutical dosage forms, in the manufacturing operations.
Core Competencies
- Knowledge on manufacturing of pharmaceutical dosage forms and relevant MES expertise.
- Experience in defending process in regulatory audits/inspection.
- Preferably experiences in good understanding of manufacturing and quality systems.
Core Competencies
- Knowledge on manufacturing of pharmaceutical dosage forms.
- Experience in defending process in regulatory audits/inspection.
- Preferably experiences in good understanding of manufacturing and quality systems.
Standards, Processes & Policies
- cGMP and application of quality management systems.
- Good documentation practices.
- Technical writing and document review skills.
- Ability to write and revise standard operation procedures (SOP) and related manufacturing and packaging documents.
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.
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