Senior Executive

Job Description

1. Management of RM/PM/CM section including all required documents review and approval including timely support to manufacturing activity with cGMP compliance.
2. Management of sample management section including all required documents review and approval including timely support to manufacturing activity with cGMP compliance.
3. Preparation of SOP’s/ STP’s/ equipment URS/ Qualification/ Study protocols/ reports pertaining to RM/PM section.
4. Review of equipment URS/ Qualification protocols/ reports pertaining to Raw Material/ Packaging Material/ Analytical section.
5. The candidate should be conversant with Quality module of SAP system.
6. Timely Updation of RM/PM/CM and water analysis results in SAP system.
7. To ensure timely In-house calibration/ verification of RM/ PM/ Analytical equipment’s as per the approved procedures and calibration/ verification frequency along with approved documentation.
8. To ensure the testing of pre-purchased RM/PM/CM samples for Vendor qualification activity of newly identified vendors.
9. The candidate should be conversant procedure for procurement of chemicals/ Reagents/ consumables and maintain their inventory records.
10. To Ensure cGMP compliance in laboratory and ensure that the laboratory is always maintained in audit ready status.

Work Experience

8 to 10 years 

Education

Competencies