QMS

- Manage and administer QMS modules deviations, CAPA, change control, OOS/OOT, complaints, and audit trail review
- Investigate deviations/non-conformances, perform root cause analysis (RCA) using tools like Fishbone, 5-Why, FMEA
- Draft, review, and implement CAPAs; track effectiveness checks
- Handle change control assessments for equipment, process, and system changes
- Support internal, customer, and regulatory audits (MHRA, WHO-GMP, EU-GMP)
- Ensure closure of audit observations within timelines
- Review and approve SOPs, protocols, and quality records
- Support electronic QMS platforms (Amplelogic, ERP etc.)

CSV (Computer System Validation)

- Prepare and execute validation documents — URS, FRS, DQ, IQ, OQ, PQ, and Validation Summary Reports
- Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity (ALCOA+) principles
- Perform risk assessments for computerized systems (GxP-critical systems, LIMS, ERP, Amplelogic QMS software)
- Support periodic review, revalidation, and system decommissioning
- Coordinate with IT and system owners for validation lifecycle management
- Review audit trails and access control configurations for data integrity compliance

📌 Senior Quality Assurance Executive (Mumbai)
🏢 V S International
📍 Mumbai