Process Validation - QA

USV PRIVATE LIMITED; Gujarat; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a Quality Assurance professional to oversee end-to-end validation, documentation, and regulatory compliance for manufacturing processes and products. The role leads CAPA, deviation handling, change control, and QbD-based CPP/CQA definition, while coordinating with Production, R&D, QC, Regulatory Affairs and Supply Chain.

Audits and inspections will require proactive preparation and strong data-driven decision making.

Responsibilities

• Oversee 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 SOPs.
• Lead investigation, root cause analysis (RCA), and impact assessment for market complaints from customers and regulatory authorities.
• Manage and evaluate quality deviations, OOS, and OOT related to manufacturing processes and market products.
• Formulate, implement, and track 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 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 Quality by Design (QbD) across commercial products.
• Monitor SPC data and trends to identify potential process variations before they impact finished product quality.
• Track and report 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 products.
• Lead Risk Management initiatives (PFMEA) to identify, assess, and mitigate quality risks across drug product manufacturing processes.
• Oversee Change Control to assess quality impact of changes on product validation status.
• Train and mentor junior QA staff on validation practices, complaint handling procedures, and regulatory compliance standards.

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.