Process Validation - QA

About the role

Oversee the end-to-end execution and documentation of process validation, equipment qualification, and cleaning validation activities to ensure full regulatory compliance. Draft, review, and approve critical quality documents, including Validation Master Plans (VMP), protocols, reports, Risk Assessments, and Standard Operating Procedures (SOPs).

What you'll do

• Draft, review, and approve critical quality documents, including Validation Master Plans (VMP), protocols, reports, Risk Assessments
• Lead the investigation, root cause analysis (RCA), and impact assessment for market complaints received from customers and regulatory authorities
• Manage and evaluate quality deviations, Out of Specifications (OOS), and Out of Trends (OOT) related to manufacturing processes and market products
• Conduct periodic Product Quality Reviews (PQR/APQR) to evaluate process consistency, trending, and product quality over time
• Coordinate cross-functionally with Production, R&D, QC, Regulatory Affairs, and Supply Chain to drive seamless validation runs and complaint resolutions

What you need

• SOP writing
• Root cause analysis
• SPC
• Complaint handling
• Regulatory affairs
• GMP

Good to have

• FMEA