Sr officer, QC Testing

Description:

Responsible to perform sterility testing, bacterial endotoxins testing, LBPC and bioburden testing of raw material, in-process, packing material, finished products, Stability samples and other miscellaneous samples

2. Responsible for water and pure steam sampling and analysis as per defined schedule.

3. Viable and non-viable monitoring in clean area of microbiology lab as per the defined schedule.

4. Responsible for Media fill vial observations and CCIT testing.

5. Responsible to identify and maintain EM Isolates, operating VITEK-2, isolates trend preparation.

6. Responsible for biological indicator analysis and issuance and other miscellaneous sample/protocol based studies execution.

7. To handle and distribute various samples received for microbiological analysis. To maintain the log book for the same.

8. Responsible for GPT Analysis and culture handling.

9. Responsible to participate in qualification, requalification, area qualification activities.

10. Responsible to co-ordinate with cross functional department personnel for timely completion of qualification / Validation / Re-qualification activity.

11. Responsible for daily monitoring of temperature, differential pressure, relative humidity of clean areas.

12. Verification and approval of temperature records of BOD incubators, deep freezers, walk-in incubators and cooling cabinets.

13. To perform calibration/qualification of instruments/equipment as per pre define schedule

14. EM, tested sample releases and recording, data update in LIMS.

15. Responsible to handle QMS related activities including preparation/revision of standard operating procedures, Investigations, protocol preparations, report preparation.

16. Responsible for reporting any OOS, Deviation to In-charge.

17. To maintain the inventory of microbiological media, log and status labels for all such items and reconciliation record of items / media.

18. Responsible for decontamination of media, cultures and other microbiological waste.

19. Activities shall be performing apart from assigned job responsibilities as per the instructions of concerned HOD/In-charge

Additional Responsibilities:

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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