POMS Techno-Functional SME
Net2Source (N2S)
Job Duration Long-term Contract (12+ months) Job Description Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites. 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 appropriate systems. Review technical specifications, configuration documents, and implementation deliverables. Support deployment, migration, and system upgrades. Knowledge of electronic batch records (EBR), batch execution, deviations, and manufacturing investigations. GxP & Validation Responsibilities Author and review: URS FRS 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. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites. #J-18808-Ljbffr Net2Source (N2S)Vacancy posted 3 days ago
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