Officer - QA

Purpose of Job

Mr. Atul is working in Block H parenteral qualification activity. He is involved in qualification activities and regulatory summary submission activities.

Skill Required

Roles and Responsibilites

1. Media fill and qualification summary preparation knowledge.
2. To maintain track of qualification and validation activities.
3. To prepare and review the protocols and reports. Execution of various qualification / validation activities.
4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT).
5. Co-ordinate with production and other user department for qualification/validation activities
6. Timely compile and review of qualification validation reports.
7. To review the equipment documents like calibration reports and ensure correctness of documents.
8. To perform FAT.
9. To co-ordinate with outside agencies for execution of qualification activity whenever required.
10. Identification of deviation through review and observation.
11. To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required.

Qualification Required

B. Pharm/ M. Pharm/ MSC.

Relevant skills / Industry experience

2 to 3 years experience in USFDA, MHRA, TGA approved plant

Relevant professional / Educational background

Any other requirements (If any)

Compensation / Reward