Associate Manager - MES @ Pfizer

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.
  

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