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Glenmark Pharmaceuticals

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3.9

based on 2.9k Reviews

96 Glenmark Pharmaceuticals Jobs

Assistant Manager

Glenmark Pharmaceuticals Ltd

3.9

based on 2.9k Reviews

9-18 years

₹ 10.2 - 14L/yr (AmbitionBox estimate)

Mapusa

1 vacancy

Assistant Manager

Glenmark Pharmaceuticals

posted 3d ago

Job Role Insights

Flexible timing

Key skills for the job

SAP CO Analytical Chemistry MS Office LMS Pandas Adobe Acrobat

Job Description

1. Submission of documents for regulatory submissions/filings.

2. Ensure the review of Stability sample analysis, In-Process testing, Technology Transfer, and review / release of Exhibit Finished Product reports .

3. Review of analytical reports for completeness and compliance.

4. Approval of Stability trends.

5. Send the Bio study, market samples samples for testing to the required destination as per regulatory requirement and SOP.

6. Support to site transfer of products to other sites of Glenmark or external party..

7.Prepare documents for product deficiency response and submit to regulatory affairs for product submission.

8. Review, approval of validation protocols/Reports, stability protocols, technology transfer and other master documents.

9. Responsible to attend the training sessions as per schedule (TNI) or un-schedule training sessions.

10.Responsible to ensure the team members are trained by providing training on relevant SOPs.

11.Imparting cGMP and other training to employee and ensuring adherence of the Annual Training Calendar.

12. Perform and assist self-inspection as per the annual schedule.

13. Conduct the self-inspection (internal audit) according to self-inspection (internal audit) procedure and monitor its execution, compliance and closure.

14. Ensure compliance to systems and procedures in Quality Control.

15. Provide clearance of technology transfer [Analytical].

16. Preparation, review of Standard Operating Procedures (SOPs) of Glenmark Pharmaceuticals Limited..

17. Review of OOS ,OOT , LER s and Laboratory Incidents for completeness, root cause evaluation present in the submission batches.

18. Approval of SOP register of Formats/TES in SAP and Open Text.

19. Any other activity assigned by the HOD due to any exigency.

20. IT Applications: Usage of QMS related T. Codes in SAP, Open Text, MS Office, Acrobat Reader, Departmental Drive, Skype, Outlook, GENESIS, HR Portal, ASPIRE Learning Management System, Track Wise and Internet

21. Maintain Environment, Health and Safety system as per ISO 14001:2015 ISO 45001:2018.

22. Coordination with RA RD for submission of ANDA.

23. Co ordination for sending of clinical studies samples

Employment Type: Full Time, Permanent

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What people at Glenmark Pharmaceuticals are saying

4.2

Rating based on 56 Assistant Manager reviews

Anonymous · Procurement & Supply Chain in Gangtok

Likes

Work life balance, well being, depends upon person capabilities if he or she willing to work in multiple window sections, accordingly management give them chance to work.