Title:  40005015 - Validation - G12A - Halol - II

Education        :  B. Pharm

Experience      :   1+ years 

• Key Responsibilities:

• Execution, compilation and compliance of qualification and requalification activities of Equipment’s, Utilities and Facility for sterile formulations.
• Review of Qualification Protocol and Qualification Report.

Tasks:

1. HE is authorize to sign (as a doer or reviewer):

1. Qualification protocol/ Report.
2. Balance, Weight box and weight calibration report/ certificates and schedule.
3. Instrument calibration and equipment requalification schedule.
4. Equipment & Instrument Addition / Deletion.
5. Calibration related activity.
6. Regulatory Summary & Query response.
7. Document issuance and Retrieval.
8. Non-viable particle count test schedule and test certificates
9. Filter integrity test schedule and Filter integrity test certificates

2. Preparation and revision of QE/Validation SOPs.
3. Preparation and Updation of cGMP documents. E.g. EQMP (Equipment Qualification Master Plan).
4. Temperature mapping activity.
5. Handling of any other activities / tasks allotted by department head.