We have a urgent Opening for the post of Dy. Manager- Quality Assurance

We have a urgent Opening for the post of Dy. Manager- Quality Assurance

Job Responsibilities:

1.To ensure that the departmental operations are carried out smoothly and effectively as per written standard operating procedures (SOP's).

2.To approve/ authorize the Standard Operating Procedure (SOP) of all departments. 

3.Co-ordination of all activities related to the QA departments.

4.Co-ordination with other interfacing departments. 

5.To ensure that all the activities at the site are carried out as per cGMP / SOPs. 

6.To ensure the completion of activities assigned to the department within the time frame and as per the requirements. 

7.To impart and ensure continuous training of the staff and workmen to keep them up to date with latest cGMP and statutory requirements.

8.To approve BMRs and other relevant documents related to quality of product.

9.To approve the qualification protocol of process area, instrument and equipment of quality division. 

10.To ensure validation program to perform validation of Process, Cleaning procedure, analytical methods etc.

11.To monitor that all the records and the documents are maintained as per statutory requirements.

12.Approval of Deviation, Change Control proposal, OOS Results and Product failure Investigation and Rework/Reprocess, to ensure CAPA for the same

13.To plan and implement and compliance of self-inspections & Internal audits.

14. Handling of the customer complaints forwarded by marketing Department and their investigations.

15.Batch release, rejection and recall

16.To evaluate Risk assessment of process, equipment and system

17.To ensure the compliance of overall quality system at SBL, Masar.

18.Review of trend data analysis and APQR.

19.To ensure compliance of VMP.

20.To ensure DMF filling with proper data.

21.To authorize for DMF, CTD, Letter of Access, annual update distribution.

22.To handle International Regulatory Affair events.

23.To review DMF deficiency and to initiate for corrective and preventive action.

24.To collect online information from the regulatory authority website, implement and improve the quality system..

Industry : Pharmaceutical (API)

Company Name : Sterling Biotech Ltd (API)

Location : Vadodara (Masar Village)

Qualification : B.Sc , M.Sc . B.Pharm , M.Pharm

Experience : 10 to 15 yrs (Only in QA) - (API Pharma Exposure Must)

Salary : Negotiable

Interested candidate can send there resume with following detail on : 

Email Id : Kishor_makwana@sterbio.com

1. Total Work Experience : 

2. Current CTC : 

3. Expected CTC :

4. Notice Period :

Kishor Makwana

HR Department

7874726491