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 current 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 - 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. Information & Business Tech

📌 Associate Manager - Mes (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam