Process Validation - QA

USV; Vadodara; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

USV is seeking a Quality Assurance leader to oversee end-to-end process validation, equipment qualification, and cleaning validation to ensure global cGMP compliance. You will draft and approve critical quality documents, lead RCA investigations, and manage CAPAs arising from market complaints and audit findings.

You will collaborate across Production, R&D, QC, Regulatory Affairs, and Supply Chain to drive validation runs, risk assessments, and product quality reviews.

Qualifications

• Draft, review, and approve critical quality documents, including Validation Master Plans (VMP), protocols, reports, Risk Assessments, and Standard Operating Procedures (SOPs).
• Lead investigations, root cause analysis (RCA) and impact assessment for market complaints from customers and regulators.
• Manage deviations, OOS, and OOT related to manufacturing processes and market products.

Responsibilities

• Oversee end-to-end execution and documentation of process validation, equipment qualification, and cleaning validation activities to ensure regulatory compliance.
• Coordinate cross-functionally with Production, R&D, QC, Regulatory Affairs, and Supply Chain to drive validation runs and complaint resolutions.
• Act as primary QA contact for internal quality audits, client audits, and health authority inspections (e.g., USFDA, EMA).
• Define CPPs and CQAs while implementing QbD across commercial products.
• Monitor SPC data and trends to identify process variations before impacting product quality.
• Track KPIs and quality metrics related to process capabilities and complaint resolutions to senior leadership.

Job description

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.