Senior Quality Assurance Executive

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