Title:  Manager 1

1.

To facilitate harmonize and consistent implementation of Quality System and procedures at site alignment with Corporate Quality Policies/Procedures.

2.

To review documents pertaining to QMS & Compliance.

3.

Responsible for ensuring compliance of Quality Management System.

4.

To attend Site Training Program as per site training program and Global Quality Standards requirements.

5.

Dossier documents Submission after review against request received from Corporate regulatory affairs.

6.

Query response for submitted dossier against request received from Corporate regulatory affairs.

7.

Export dispatch related query response for approved art work of printed PM, Primary-packing material, overprinting and if other requirement is there.

8.

Export Harmonization activity between existing and new change implement for Product.

9.

Review and approval of change control and deviation through QMS software and prior approval activity from Regulatory if require as an impact analysis with require detail.

10.

Initiation of extension and variation proposal through QMS software

11.

Regulatory impact handling for Pharmacopoeia change like IP,BP,USP implementation for export market products.

12.

Location RA - Approval to Process Validation summary. Other departmental documents where signature require as location regulatory approval like  APR, etc.

13.

Product approval package review, approve and share approval detail to respective department.

14.

Any Additional activity allocated by the department head and site head.