Prepare and execute validation documentation including Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

· Perform risk assessments for computerized systems as per GAMP 5 categorization.

· Execute test scripts and document results, ensuring traceability between requirements and test cases.

· Manage deviations, discrepancies, and CAPAs identified during validation activities.

· Support periodic review, change control, and system decommissioning activities.

· Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and other applicable regulatory guidelines.

· Collaborate with cross-functional teams including IT, QA, and business process owners.

· Maintain validation documentation in line with data integrity (ALCOA+) principles.





· Support internal and external audits/inspections related to computer system validation.

· Perform User Management, Audit Trail Reviews and Periodic Reviews related to Laboratory Softwares.

Required Skills & Qualifications:

· 3 - 5 years of experience in Computer System Validation within a pharmaceutical, biotech, or medical device company.

· Bachelor’s degree in computer science, Life Sciences, Engineering, Pharmacy, or related field

· Solid knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.

· Hands-on experience with validation lifecycle documentation (URS, FRS, DS, IQ/OQ/PQ, RTM).

· Good understanding of SDLC and change control processes.

· Strong written, analytical and verbal communication skills.

· Ability to work independently and manage multiple validation projects simultaneously.

📌 QA Executive IT (CSV) (Thane)
🏢 HiMedia Laboratories
📍 Thane