POMS Techno functional SME

Key Responsibilities

• Gather and analyze business requirements from Manufacturing, Quality, Validation, and IT stakeholders.
• Translate business requirements into MES functional specifications and system designs.
• Configure and support POMS MES workflows, electronic batch records (EBR), recipes, and manufacturing processes.
• Facilitate requirement workshops, fit-gap analyses, solution design reviews, and UAT sessions.
• Collaborate with manufacturing teams to optimize production processes through MES capabilities.
• Ensure MES solutions align with business processes, GMP requirements, and regulatory expectations.

Technical Responsibilities

• Configure and support POMS MES modules and integrations.
• Troubleshoot MES production issues and perform root cause analysis.
• Support Interface Development And Integration With Review technical specifications, configuration documents, and implementation deliverables.
• Support deployment, migration, and system upgrades.

Knowledge and Skills

• Knowledge of electronic batch records (EBR), batch execution, deviations, and manufacturing investigations.
• GxP & Validation Responsibilities: Support CSV (Computer System Validation) activities. Author And Review URSFRS Design Specifications IQ/OQ/PQ Protocols Traceability Matrix Validation Summary Reports Ensure Compliance With FDA 21 CFR Part 11 GAMP 5 GMP requirements Data Integrity guidelines

Desired Soft Skills

• Strong stakeholder management.
• Excellent communication and documentation skills.
• Ability to work with cross-functional global teams.
• Strong analytical and problem-solving abilities.
• Leadership in driving workshops, solution reviews, and issue resolution.

Mandatory Skills

• Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment.