Manager Technical Operations

Job Description Rev. no.: 00

Followings will be the responsibilities of the position holder:

1. Act as receiving team for new and reformulated product from I&D to AHPL Baddi.

2. Scale up/scale down for new and existing products.

3. Preparation of MMD of new and existing products.

4. Review of sampling plan for engineering & process validation.

5. Technical inputs for product improvisation w.r.t equipment and process, formulation, or shelf-life changes through appropriate QMS.

6. Handling of reprocessing, reworking of existing formulation.

7. To support for failure investigation or exceptions (as per applicability) OOS/OOT observation.

8. All documentation & process steps for trial/non-commercial batches manufactured in production facilities.

9. New/ Old material approval (API/Excipient) – Technical input if required, revision of TD & BD limits.

10. Products externalization/ internalization from AHPL, Baddi to LL/ TP and vice versa.

11. Preparation of Standard operating procedure (SOPs) pertaining to department.

12. Analytical/Formulation support (troubleshooting) for existing products (including method development).

13. Cost saving initiative related to formulation and process.

14. To support in document preparation, review and approval of documents related to production.

15. To ensure overall compliance related to technical operation and production department.

16. To review and approve documents wherever approved chemist review and approval is required,

In absence of the position holder, the sub-ordinate Executive / Manager working in the section or

the authorized designee (as applicable) shall be responsible for day to day working.

Signatures

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Position holder

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Authorized by