U
USV PRIVATE LIMITED
QA - Process Validation and Customer Complaint
Skills
Testing & QARisk Management
12 days ago
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Important information
Contract type:
Permanent
Location:
Vadodara, Gujarat, India
Work mode:
Onsite
Published on:
13 October 2026
What they need
- 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.
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