Associate Manager - MES

​​Operation 

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• 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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