Intas Pharma Hiring Assistant Manager, M.Pharm, MSc Apply

As one of the world's leading pharmaceutical companies, Intas is committed to fulfilling the unmet global medical needs through comprehensive, progressive and affordable medical products. To fuel its ever- expanding vision, Intas Pharmaceuticals is looking for elite professionals aiming to take their careers to the next level through the following positions.

Post : Assistant Manager

Experience : 10-12 Years
Qualification : M.Pharm / M.Sc

Job Description for QA - 21 CFR Compliance Role
1. Must have experience for the operation of Manufacturing, QC systems
2. Expert in Dl review and Technical/Operational compliance of GxP software/application
3. Must have practical understanding of Data integrity requirements for computerised system
4. Thorough understanding of Data Governance and Data Lifecycle approaches
5. Expert in Audit Trail and Electronic data review, Periodic review of Computerized systems
6. Review of Alarm management and Recipe Management processes
7. Expert in review of Change Control, Incident/Deviation investigation related to Computer systems
8. Sound understanding of IT processes such as Backup, Restoration and User access Management
9. Involved in Review of Computer System Validation documents
10. Added advantage for the validation of Enterprise (e.g. SAP, QMS, TMS, LIMS, eBMR, L1/L2 integration, SCADA, CDS, Serialization)
11. Perform Functional Risk Assessment (FRA) and mitigate the gaps of CFR/EU non-compliances.
12. Represent during audit and define the response for the observation, monitor and timely closure
13. Interpersonal relationship and work beyond boundaries with cross functional team
14. Good communication skills i.e both speaking and writing