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.