- Experience: 8 to 12 years of hands-on Quality Assurance experience in Pharmaceutical or Biotech manufacturing.

- Organizational Stability: Minimum of 2+ years of continuous service in the current organization (candidates with frequent job hops will be disqualified).

- Communication: Fluent written and spoken English proficiency for handling client communications, technical writing, and regulatory audits.

- Process Validation &
- Tech Transfer: Proven leadership in drafting, executing, and reporting end-to-end Process Performance Qualification (PPQ), Continuous Process Verification (CPV), and technology transfer/scale-up activities.

- Quality Risk Management (QRM): Applied expertise in using FMEA and HACCP tools to establish Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

- Customer Complaints &

- RCA:



Full lifecycle management of customer complaints and deviations using advanced RCA tools (5 Whys, Fishbone, Fault Tree Analysis).

- CAPA Management: Direct responsibility for executing the complete Corrective and Preventive Action (CAPA) workflow through to effectiveness verification.

- Regulatory &

- Audit Expertise: Demonstrated success hosting and facilitating internal, vendor, and regulatory audits under USFDA (21 CFR Parts 11, 210, 211), EU GMP, and ICH (Q8, Q9, Q10) guidelines.

- Technical Documentation: Experience authoring and approving SOPs, Validation Master Plans (VMP), validation protocols, and comprehensive investigation reports.

- eQMS &

- Software Proficiency: High proficiency operating within TrackWise (QMS), ValGenesis (VMS), MES, and statistical tools like Minitab.

📌 QA - Process Validation and Customer Complaint (Vadodara)
🏢 USV Private
📍 Vadodara