Associate Manager - MES

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.

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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