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
Good 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
