R & D doc cell.

Role & responsibilities

1.

Market samples receiving, entry and stock maintenance.

2.

List updations, equipment and SOPs, Product code list updation

3.

RM BOM preparation and checking of new product solid, liquid and semi-solid dosage form.

4.

Preparation of MFR/MPR/PDR of solid, liquid and semi-solid, injectable dosage form.

5.

Sample upkeep Withdrawal and Storage of Sample.

6.

RA related mail communication, document follow ups, preparation and send as per urgency and priority of documents.

7.

List updations (RM/PM/Stability samples)/ Innovator samples/ Equipments.

8.

BOP preparation and corresponding mail correspondence. Responsible for QMS activity                                                   MFR preparation and corresponding change control documentation.

9.

Document preparation as per regulatory requirement and commercial MFR preparation and revision with change control.

10.

BMR/BPR filling as per dossier requirement/ Dossier related documentation

11.

Filing of documents and list updation.

12.

Commercial Work Order Request form entry & Clearance.

13.

Audit related documentation

14.

New item code creation

15

Change control initiation for new product development & tech transfer

Preferred candidate profile Candidates preferred from reputed pharma background