Job Summary: We are looking for an IT QA Engineer with 1–2 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in Computer System Validation (CSV), GxP compliance, and IT Quality Assurance activities. The role involves ensuring regulatory compliance, supporting validation activities, managing IT systems, and maintaining documentation in accordance with applicable quality standards and SOPs.

Experience: 1–2 Years

Location: Baddi/Mahape Navi Mumbai

Notice Period: Immediate / 15 Days Preferred

Job Requirements

Experience in Pharma domain

Knowledge of GxP, 21 CFR Part 11

Experience in Computer System Validation (CSV)

Knowledge of IQ, OQ, PQ documentation

Valuable communication skills

Key Responsibilities

● User Management. (ID Creation, deactivation, Unlocking, Modification, Password Reset.) ● Data backup and Restoration.

● Backup validation.

● Responsible for data archival as per requirements

● Maintain the logbooks as per requirement.





● Desktop policy implementation and review. (Privileges, Roles and Group)

● Date and Time verification

● To provide support to QA department for audit trail review and periodic user management review

● Compliance & support during internal, customer and regulatory audits.

● Support and coordination with Vendor for troubleshooting of manufacturing equipments / systems.

● Assistance to the user department in equipment qualification / software validation.

● Preparation and execution of all documentation activities as per respective SOPs

● Ensure required documentation and validation of IT systems as per procedures

● Preparation and execution of all documentation activities like workstation qualification / requalification, Preventive Maintenance, Schedule, Preventive Maintenance, History Management, Document issuance.

Work Location: In person

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