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IT Quality Assurance (QA) & Computer System Validation (CSV)

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Description

Lead CSV & IT QA for pharma manufacturing, ensuring GxP compliance, ERP validation, data integrity, audit trails, risk management, change control, SOPs, supplier oversight, regulatory audits, and validated system lifecycle.

Required Candidate profile

Bachelor’s in Pharmacy/IT/CS with 6–10 years in Pharma QA/CSV, ERP validation, and data integrity. GAMP 5, 21 CFR Part 11, Annex 11; experience with LIMS, MES, SCADA, and greenfield sites.

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