Senior Quality Assurance Qualification and Validation Specialist

Senior Executive – QA

Qualification & Validation Specialist with strong expertise in Equipment & Facility Qualification, Computer System Validation (CSV), and Quality Management Systems (QMS). The ideal candidate must possess strong technical knowledge, regulatory understanding, and hands‑on experience in GxP‑regulated environments

Equipment Qualification : The candidate  will responsible for Review and preparation of the Equipment Qualification Protocols and Final reports. Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment.Review of periodic validation like, steam sterilizer validation, Thermal mapping reports, HVAC qualification, LAFU/BSC qualificationGood understanding on the regulatory guideline and expectation.

Computer System Validation : The candidate has good experience in handling of CSV activity of server base application, enterprise application, standalone application. Good understanding on the 21 CFR part 11,  EU ANNEX 11 and GAMP guideline requirement. The candidate should be technically strong on the handling of PLC / HMI / SCADA base equipment qualification.Prepare URS, FS, Risk Assessments, IQ/OQ/PQ protocols, RTM, and Validation Summary Reports.Verification of user access management, data backup, archival, and disaster recovery mechanisms.

Quality Management System: Experience in handling of QMS related activities: Change control, Deviation, CAPA.Experience in handling of Deviation investigation.

Documentation: Experience in drafting of technical reports, Quality risk assessment, water trend report,Preparation and review of Quality Risk assessment.Annual equipment performance review report and perform gap assessment against regulatory guideline

Experience Level

Senior Level