Job Title: Executive/Sr. Executive - Quality Assurance (IPQA)
Roles and Responsibilites
1. | In process Quality Assurance activity in Production and warehouse area |
2. | Provide line clearance as per SOP |
3. | Monitoring and QA rounds in production and Warehouse |
4. | Sample verification against TRF / BPCR |
5. | Carry out Semi-finished / finished product sampling for release, stability study and control samples |
6. | To send samples along with TRF to Quality control laboratory |
7. | Participate in media fill, process validation, cleaning validation activities as per requirement |
8. | Timely communication and co-ordination with all the stake holders |
9. | Participation in Change control, Deviation & Investigations as per requirement |
10. | Preparation / review of documents like; SOPs, risk assessment report and any other document as per requirement |
11. | Timely review of Batch Process & Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data |
12. | Timely review of executed batch records and associated data |
13. | Keep vigilance on production operations |
14. | Review of Analytical Reports as per requirements |
15. | Participation in Audits & Compliance activity |
16. | In addition of above, any other responsibility assigned by Superior / HOD |
17. | Final release of critical intermediate and drug substance batches in LIMS and SAP |
18. | Risk assessment preparation and review |
19. | Draft MFR/BPCR/BPR review |
Qualification Required
B. Pharm / M. Pharm
Relevant skills / Industry experience
2-10 Years with Injectables or Biotech Induastry in IPQA department
Plasma Fractionation Unit, Ahm, GJ, IN, 382210