Harman Finochem Ltd | Senior General Manager | aurangabad

4 days ago

aurangabad, India Harman Finochem Ltd Full time

Dear Candidates,


Greetings of the day

We are a leading Pharmaceutical company into manufacturing of API & OSD for Regulated markets.


Job Location - Chikhalthana, Aurangabad.

Education - M.Sc.- Chemistry / Organic Chemistry

Experience -20 to 29Yrs. in API Pharma


We are currently hiring for the position of "Senior General Manager/ Site QA - API":


Job Description:

1.To support in review of executed LMRs/ BMRs and worksheets. Also to follow up on any deviations or delays based on the review.

2.Support V.P. Quality in site preparation for external audits for both the sites.

3.Review QMS documents viz. Change control, Deviations, OOS, OOT, OOC, Incidences QRM, Customer Complaints, Returned Goods & Reprocessing etc.

4.Review of the MFRs.

5.Follow up of customer audit reports and its compliance for both the sites.

6.Collecting data and other information for preparation of annual product quality review.

7.To take initiative in reviewing and updating of all Q.A. procedures.

8.Ensure systems are followed for qualifying, maintaining and calibrating critical equipment's in production and engineering in timely manner.

9.To ensure CAPAs are reviewed and implemented across the site.

10.To ensure data integrity across the site.

11.To ensure Quality Risk Management procedure is followed.

12.To train employees regarding Q.A. Procedures and CGMP systems across the factory.

13.Responsible for vendor qualification.

14.To release or reject the finished products based on their merits.

15.Involve in investigation of Complaints, OOS, OOT, OOC, Deviations, Returned goods etc.

15. To review and approve all specifications of raw materials, packing Materials, intermediates, in-process finished products etc. To approve all Q.A.,Q.C. procedures & participate in review of SOPs (All Departments).

16. Ensure systems are followed for validation.

17. To carry out external audits as part of vendor qualification.

18. To take part in internal audits.

19. To ensure adequacy of resources in QA/QC/Microbiology departments.

20. FAMI-QS / Feed Safety Compliances / Halal Assurance system (HAS) Compliances

21.Review and approve the documents in Caliber QAMS/DMS/Nichelon S/W, Batch release in SAP and perform various activities in SAP.

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