Job Description

1. Responsible to perform Quality Function responsibilities pertaining to Validation.
2. Responsible for preparation and review of URS, DQ and vendor/ supplier’s documents related to qualification.
3. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
4. Responsible for review of the master and executed documents (SOP’s, BMR, BPR, QRM, Investigations, Planner, Calibration certificates, Trends for Environmental monitoring, WFI, Pure Steam etc.) of cross functional team (CFT).
5. Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
6. Responsible for preparation, review and approval of media fill and hold time protocol and report.
7. Responsible for preparation and review of Validation/Qualification Protocols and reports i.e. Process Validation, Equipment Validation, Cleaning Validation, Media fills etc. of Parenteral Unit- III
8. Responsible for review of the master and executed documents (SOP’s, BMR, BPR, QRM, Investigations, Planner, Calibration certificates, Trends for Environmental monitoring, WFI, Pure Steam etc.) of cross functional team (CFT) for Parenteral Unit III
9. Responsible to identify training needs and impart training of SOP's and developmental trainings within the department and for other department.
10. Responsible to provide and fulfill the documents requirement of regulatory affairs department for filing or other requirements.
11. Responsible to final release the materials (FP, RM, PM) in LIMS.
12. To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
13. Responsible for the assessment of Change Control, Deviations, CAPA, Investigation etc.
14. Responsible to perform the in-process test at different stages as per batch document/SOP.
15. Responsible to review the in-process and finished product COA before batch release.
16. Responsible to monitor cGMP compliance at shop floor, to provide line clearance at applicable stages and perform the AQL for semi-finished and finished goods.
17. Responsible for reserve sample collection, management, periodic review and destruction as per Procedure and tracking and collection of stability sample as per SOP/protocol.
18. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.

Life Science or Pharmacy Graduate