Department – Production – QMS
Designation – Officer / Executive
Experience – 2 to 5 years
Qualifications – B. Pharm, M. Pharm, M.Sc.
Location – Moraiya
1. Coordinate digitalization projects and ensure timely execution.
2. Collaborate with Production, QA, QC, Engineering, and IT teams.
3. Gather and document business requirements for digital solutions.
4. Support implementation of IPQC digital systems, eCleaning, eLogbook, eLine clearance and other digital systems.
5. Preparation, review, and execution of PQ (Performance Qualification), IQ (Installation Qualification), and OQ (Operational Qualification) documentation.
6. Handling Change Management activities and ensuring compliance with Quality Management System (QMS) requirements.
7. Working knowledge of QMS tools, document control, deviation handling, CAPA, and risk assessment processes.
8. Track project timelines, milestones, and deliverables.
9. Ensure compliance with GMP, GxP, 21CFR Part 11 and data integrity requirements.
10. Coordinate system validation, testing, and user acceptance activities.
11. Monitor project risks, issues, and corrective actions.
12. Prepare project reports, dashboards, and management presentations.
13. Conduct user training and support change management for new systems.
