Ciron Drugs & Pharmaceuticals
CSV QA Officer
Skills
1 month ago
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Important information
Contract type:
Permanent
Salary:
₹250,000 – ₹500,000 / year
Location:
Boisar, Maharashtra, India
Work mode:
Onsite
Published on:
22 September 2026
What they need
Computer System Validation (CSV) Officer / Senior Officer within the Quality Assurance (QA) department.In a pharmaceutical injectable manufacturing facility, this role bridges IT/software compliance with strict regulatory standards (such as USFDA, MHRA, and WHO guidelines).Core Job Responsibilities
- Validation & Compliance: Formulate, review, and execute validation protocols (IQ/OQ/PQ) for computerized systems, automated manufacturing equipment, and lab software.
- Data Integrity Assurance: Audit systems to ensure absolute compliance with ALCOA+ principles and 21 CFR Part 11 regulations.
- Risk Assessment: Perform periodic system assessments, gap analyses, and mitigation strategies for software used in the production of injectables.
- Audit Readiness: Maintain audit-ready validation documentation and defend CSV processes during regulatory and client inspections.
- Issue Resolution: Investigate software deviations, track system bugs, and implement Corrective and Preventive Actions (CAPA).
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