- 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).
- 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.
- Formulate, implement, and track Corrective and Preventive Actions (CAPA) arising from process failures, audit findings, and market complaints.
- 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.
- Act as the primary Quality Assurance point of contact for internal quality audits, client audits, and health authority inspections (e. g., USFDA,



EMA).
- Define critical process parameters (CPPs) and critical quality attributes (CQAs) while implementing Quality by Design (QbD) principles across commercial products.
- Monitor statistical process control (SPC) data and trends to identify potential process variations before they impact finished product quality.
- Track and report key performance indicators (KPIs) and quality metrics related to process capabilities and complaint resolution timelines to senior leadership.
- Ensure strict adherence to global cGMP standards, ICH guidelines, and regional regulatory requirements for all commercial and validated products.
- Lead Risk Management initiatives (PFMEA) to identify, assess, and mitigate potential quality risks across drug product manufacturing processes.
- Oversee the Change Control management system to assess the quality impact of raw material, process, or equipment modifications on product validation status.
- Train and mentor junior QA staff on current validation practices, complaint handling procedures, and regulatory compliance standards.

📌 Process Validation - QA (Gujarat)
🏢 USV Private
📍 Gujarat