IT Documentation -Officer
Job Description
Job Description: Candidates should have a mix of technical (Infrastructure) and GMP Documentation work.
Task Description:
- Knowledge of IT Hardware/Network/Software Application components.
- Sound knowledge of Data backup technologies & SQL Database.
- Sound knowledge of Audit trail review of instrument/Equipment/Computerized systems.
- Preparation & perform validation documentation of PLC/SCADA, Computerized systems.
- Sound knowledge of US FDA, 21 CFR Part 11, EU Annex 11 and GAMP5.
- Sound knowledge of risk based approach of computerized systems.
- Shall be able to prepare and review SOP related to computerized systems.
- Knowledge of investigation of incidents of computerized systems.
- Compliance of IT & across functional SOP (Backup, IT Inventory, User Management, Equipment Software, etc.…)
- Documentation (Change Control, CAPA, Deviation, Breakdown (Incident), On Job Training, Training need Identification, Issuance & Retrieval)
Required Experience:
Minimum 2 years’ experience in computerized system validation in laboratory and production environment of Pharmaceuticals industry.