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 of BMR / BPR, scale-up and placebo batches.


3. Review of executed BMR/BPR of commercial and exhibit batches for batch release.


4. Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats.


5. Login and review of quality system documents such as Deviation and IPOOS.


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 and Executed documents.


9.  Participation in investigation of failures and release of batches.


10.  Shop floor monitoring and ensuring the compliance as per designed procedures.

 Preparation, review and tracking of hold time protocols / reports

Work Experience

5 to 8 year

Education

Competencies