Associate Manager - MES

Role overview

This position supports manufacturing execution activities for pharmaceutical operations, with a strong focus on MES, SAP, EBR, and label management processes. The role is centered on keeping shop-floor systems ready, resolving production-support issues quickly, and ensuring all work aligns with cGMP, safety, and internal quality standards.

Operations

• Create and simulate AMPS/FTPS recipes so they are easy for users to run and remain aligned with site-specific needs.
• Make sure recipes are prepared and ready in line with the weekly manufacturing schedule.
• Draft and update electronic batch records using approved MMR/MBR and validated source documents.
• Support end users in the day-to-day use and execution of EBRs.
• Investigate and resolve AMPS, SAP, and MLM issues by identifying root causes in detail.
• Take proactive ownership of implementation projects and system enhancements.
• Monitor documentation activities such as SOP updates, CAPA closures, change controls, change-action items, and investigations.
• Act as the first contact for electronic manufacturing-related issues.
• Escalate unresolved MES execution issues to the Shift Manager-MES or the relevant support teams.
• Maintain strong working knowledge of manufacturing execution systems.
• Deliver training to executing personnel on the EBR platform.
• Support troubleshooting for SAP and AMPS shop-floor interface issues.
• Track revisions to AMPS recipes when batch records are revised or newly created.
• Create BOMs and production versions in SAP.
• Ensure BOM and production-version data in SAP is ready for building AMPS recipes.
• Handle SAP-related issues and provide floor support.
• Clear SAP stock issues and IDOC messages as required.
• Follow up on BT tickets and track their resolution through batch release.
• Contribute to and execute upcoming MES projects.
• Manage or design the Manufacturing Label Management system to keep it operating smoothly.
• Coordinate with support functions to ensure production runs without disruption.
• Ensure all activities follow applicable procedures.
• Keep records complete for every activity performed.
• Review related protocols as required.
• Raise change controls for documents and equipment, then drive closure and implementation within the required timeline.
• Spot deviations or exceptions and inform the reporting manager through the proper process.
• Follow safety procedures and GMP/GDP practices consistently.

Quality management and compliance

• Ensure every operation complies with cGMP, safety rules, and Pfizer integrity principles.
• Participate in internal as well as external audits, including regulatory and non-regulatory inspections.
• Prepare procedures for the assigned area in line with regulatory expectations and cooperative guidelines/practices.
• Complete all work-related documents online in accordance with cGMP and GDP, and submit them to the documentation cell on time.
• Prepare daily activity reports.

Training

• Attend all scheduled training for applicable procedures.
• Train teammates on relevant procedures and continue learning within the assigned area.
• Provide AMPS, SAP, and MLM training to new joiners and refresher sessions to end users.

Requirements

• Graduate or postgraduate degree in Pharmaceutical Science or Engineering.
• 6 to 10 years of experience in manufacturing pharmaceutical dosage forms and manufacturing operations.
• Working knowledge of pharmaceutical dosage-form manufacturing and MES-related systems.
• Experience presenting and defending processes during regulatory audits or inspections.
• Solid understanding of manufacturing and quality systems is preferred.
• Strong knowledge of cGMP and quality management systems.
• Good understanding of good documentation practices.
• Ability to write and revise SOPs and associated manufacturing/packaging documents.
• Technical writing and document-review capability.

Additional information

Work location assignment: On premise in Visakhapatnam, Andhra Pradesh, India.

This employer follows equal opportunity hiring practices and complies with applicable employment legislation in each jurisdiction where it operates.

Applicants are expected to follow the employer’s candidate AI-use guidelines during recruitment.

Department: Information & Business Tech.

Extra capability areas mentioned in the role include SAP stock clearance, IDOC message clearance, BT ticket follow-ups, batch release tracking, and support for implementation and enhancement projects.

The role also involves coordination with functional departments, protocol review, change-control management, and adherence to safety, GMP, and GDP requirements.