USV Private Limited-QA Process Validation Assistant Manager

Pharmaguidances; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

USV Private Limited is seeking a QA Process Validation Assistant Manager to oversee end-to-end validation activities and documentation for process validation, equipment qualification, and cleaning validation, ensuring full regulatory compliance.

The role requires drafting and approving critical quality documents, leading investigations and CAPA activities, and coordinating with production, R&D, QC, and regulatory teams. The position is based at Vadodara (Savli) with a 21 Nov 2026 end date.

Qualifications

• Oversee end-to-end process validation execution and documentation.
• Draft, review, and approve critical quality documents (VMPs, protocols, reports).
• Lead investigations, root cause analyses, and impact assessments for deviations and complaints.
• Manage CAPA, OOS/OOT, and product quality trends across processes.
• Ensure compliance with global cGMP, ICH guidelines and regulatory requirements.
• Lead PFMEA and risk management initiatives across manufacturing processes.
• Monitor SPC data and KPIs; drive quality improvements.
• Coordinate with Production, R&D, QC, Regulatory Affairs, and Supply Chain.

Responsibilities

• Oversee Validation Master Plans, protocols, and reports to ensure regulatory compliance.
• Coordinate audits and health authority inspections.
• Define CPPs and CQAs; apply Quality by Design principles.
• Mentor and train junior QA staff in validation practices and regulatory standards.

Skills

Quality Assurance

Process Validation

CAPA

RCA

cGMP

ICH Guidelines

PFMEA

SPC

QbD

Cross-functional Coordination

Job description

# USV Private Limited-QA Process Validation Assistant Manager#### *USV Private Limited-QA Process Validation Assistant Manager*USV Private Limited is a prominent Indian multinational pharmaceutical and biotechnology company founded in 1961, specializing in diabetes and cardiovascular therapeutics. Headquartered in Mumbai, it is a market leader in Oral Anti-Diabetic (OAD) drugs and offers a diverse portfolio, including APIs, biosimilars, and injectables, alongside consumer healthcare products like Sebamed.Track Biotech**Post :** Assistant Manager – Process Validation – QA**Job Description** 1. Oversee the end-to-end execution and documentation of process validation, equipment qualification, and cleaning validation activities to ensure full regulatory compliance. 2. Draft, review, and approve critical quality documents, including Validation Master Plans (VMP), protocols, reports, Risk Assessments, and Standard Operating Procedures (SOPs). 3. Lead the investigation, root cause analysis (RCA), and impact assessment for market complaints received from customers and regulatory authorities. 4. Manage and evaluate quality deviations, Out of Specifications (OOS), and Out of Trends (OOT) related to manufacturing processes and market products. 5. Formulate, implement, and track Corrective and Preventive Actions (CAPA) arising from process failures, audit findings, and market complaints. 6. Conduct periodic Product Quality Reviews (PQR/APQR) to evaluate process consistency, trending, and product quality over time. 7. Coordinate cross-functionally with Production, R&D, QC, Regulatory Affairs, and Supply Chain to drive seamless validation runs and complaint resolutions.8. Act as the primary Quality Assurance point of contact for internal quality audits, client audits, and health authority inspections (e.g., USFDA, EMA). 9. Define critical process parameters (CPPs) and critical quality attributes (CQAs) while implementing Quality by Design (QbD) principles across commercial products. 10. Monitor statistical process control (SPC) data and trends to identify potential process variations before they impact finished product quality. 11. Track and report key performance indicators (KPIs) and quality metrics related to process capabilities and complaint resolution timelines to senior leadership. 12. Ensure strict adherence to global cGMP standards, ICH guidelines, and regional regulatory requirements for all commercial and validated products. 13. Lead Risk Management initiatives (PFMEA) to identify, assess, and mitigate potential quality risks across drug product manufacturing processes. 14. Oversee the Change Control management system to assess the quality impact of raw material, process, or equipment modifications on product validation status. 15. Train and mentor junior QA staff on current validation practices, complaint handling procedures, and regulatory compliance standards.Audit Quality**Additional Information** **Location :** Vadodara (Savli) **Industry Type :** Pharma/ Healthcare/ Clinical research **SBU :** Operations **Function :** Formulation Plant **End Date :** 21 Nov 2026> **Process Validation – QA Apply Online**>> ####Views: 29**Job Category:** Pharma**Job Type:** Full Time**Job Location:** Vadodara (Savli)## Apply for this positionAllowed Type(s): .pdf, .doc, .docx