Associate -MES

Operation:

To Design and simulate AMPS (Agile manufacturing production system) 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 get in depth/detailed understanding/identify root cause.

To proactively handle activities in Implementation projects and enhancements.

Tracking 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 training 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 issues 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 activities performed 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 and equipment. Ensuring their closure and implementation of changes within specific time.

Identify deviations/exceptions and escalate to reporting manager 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

Preferred Education/ Qualification:

Diploma/Graduate or Postgraduate in Pharmaceutical Science Discipline/Engineering

Experience:

0-3+ years of experience in manufacturing pharmaceutical dosage forms, in manufacturing operations

Work Location Assignment: On Premise

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Quality Assurance and Control