Associate Manager – MES Full Time NEW

• 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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