Officer

Job Description

1. Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments.
2. Review of master BMR/BPR of commercial and exhibit batches. Review and approval of BMR / BPR of Lab Note Book, scale-up and placebo batches.
3. Review of executed BMR/BPR of commercial and exhibit batches for batch release.
4. Preparation and review of APQR.
5. Monitoring & review of quality system documents such as Deviation, Change control, OOS, OOT, Market complaints, IPOOS etc.
6. In-process Quality Assurance during Production / Packing activities.
7. Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.)
8. Review of qualification / validation documents, stability data, Master / Executed documents.
9.  Shop floor monitoring and ensuring the compliance as per designed procedures.
10.  Preparation, review and tracking of hold time protocols / reports.
11.  To participate and tracking in various validation program such as process/cleaning validation etc.
12. Review & calibration of IPQA instrument / equipment’s.

Work Experience

1 to 5 year

Education

Graduation in Pharmacy

Competencies