Manager QA & Compliance

1. Responsible for GEMBA walk on the plant and facilities to highlight the changes and improvement on the plant day to day activities.

2. Responsible to monitor the QA activities on shop floor.

3. Responsible to ensure day to day shop floor activities on the production floor and accessory areas.

4. Responsible to ensure that controlled documents are in practice at the shop floor and production areas.

5. Responsible to provide trouble shooting on the shop floor, regarding maintaining compliance with existing SOPs and guidelines.

6. Responsible to ensure that QA will be available on shop floor as per the production need i.e. grant approval on duty roasters for the QA-IPC personnel.

7. Responsible for training of the QA-IPC Personnel for effective rotation of the IPC on shop floor.

8. Responsible to ensure the compliance of data integrity on batch documents and relevant Log books.

9. Responsible to ensure the destruction of production waste as per relevant SOP.

10. Responsible for review of Deviation and their investigation for root cause analysis.

11. Responsible to ensure that CAPA raised against Deviation where required.

12. Responsible for timely follow up of actions against Deviations for Deviation closure.

13. Responsible to review the online complaints arising against any non-conformity of released raw and packaging materials.

14. Responsible to provide the relevant data for management review meeting.

15. Responsible for timely revision of IPC SOPs if required and Develop new SOPs when need arise.

16. Responsible to monitor that QA-IPC lab equipment’s are up to date and operational.

17. Responsible to monitor the returned goods handling as per the respective SOPs.

18. Responsible for review of repacking / reprocess activities as per the approved procedures.

19. Responsible to complete any task assigned by the up-line manager.

Note: In the absence of the JD holder, Assistant Manager QA & Compliance is authorized to act and have complete authority over all relevant decisions.

Authorities:

1. Authorize to monitor in-process activities and resolve day to day complaints.

2. Authorize to handle the Deviations.

3. Authorize to train his team.

4. Authorize to handle Returned Goods

KEY PERFORMANCE INDICATORS

1- Ensure proper placement of updated SOPs whenever needed and make sure its implementation.

2- Ensure controlling of all the documents at plant.

3- Ensure the smooth execution & completion of the production operations in compliance with the established GMP standards.

4- Task completion.

5- Team working.

6- Ensure the reduction of shop floor observations.

JOB SPECIFICATION

Education:

M.Sc. / Pharm-D / B. Pharm

Experience:

Minimum 8 to 10 years

Skills:

o Leadership Skills

o Planning and Organization

o Deadline Management

o Good communication

o Problem Solving

o Good technical and IT skills.

o Understanding of Quality Standards, GMP Standards, Regulatory Standards.

o Any other as per business need

Job Type: Full-time

Pay: Rs180,000.00 - Rs220,000.00 per month

Work Location: In person