Associate Manager - MES

Responsibilities

• Design and simulate AMPS (Agile Manufacturing Production System) recipes to ensure feasibility and ease of user execution.
• Prepare and revise Electronic Batch Records (EBR) based on approved validated documents.
• Troubleshoot and resolve issues within AMPS, SAP, and Manufacturing Label Management (MLM) systems.
• Manage SAP activities including Bill of Material (BOM) creation, production version (PV) setup, and stock/IDOC clearance.
• Act as the primary point of contact for electronic manufacturing issues and escalate to management when necessary.
• Track documentation activities including SOP revisions, CAPA closures, change controls, and investigations.
• Conduct training for executing personnel on EBR systems and provide refresher training to end users.
• Ensure all activities comply with cGMP, safety, and Good Documentation Practices (GDP).
• Participate in internal and external regulatory audits and inspections.

Requirements

• Graduate or Postgraduate degree in Pharmaceutical Science or Engineering.
• 6 to 10 years of experience in pharmaceutical manufacturing operations.
• Deep expertise in Manufacturing Execution Systems (MES).
• Strong knowledge of pharmaceutical dosage forms and manufacturing processes.
• Proven experience defending processes during regulatory audits and inspections.
• Proficiency in cGMP, quality management systems, and Good Documentation Practices (GDP).
• Strong technical writing skills for revising SOPs and manufacturing documents.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to discovering and delivering breakthroughs that change patients' lives. We foster a culture of individual ownership and innovation to unearth new therapies that make the world a healthier place.