Quality Assurance ( Process Validation, Qualification )

Department : Quality Assurance (Process Validation, Qualification )

Designation : Officer / Executive

Experience : 2 to 6 Years

Location : Bavla, Ahmedabad

Education : M. Pharma / B. Pharma / M. Sc

Job Description : ( Process Validation )

1. To prepare standard operating procedure.

2. Issuance of controlled Format to concern department.

3. Provide the required documents to regulatory for dossier submission.

4. Follow – up with concern department to complete the documentation.

5. To prepare protocol for Process Validation, cleaning validation and hold time validation study.

6. To execute process validation, hold time validation and cleaning validation activity and co-ordination with all departments for planning.

7. Review of protocols for process validation, cleaning validation and hold time validation

8. Preparation and communication of critical process parameters based on process validation study

9. Preparation and communication of hold time to production based on obtained hold time study reports.

10. Sample collection, submission, report compilation and preparation of summary report for process validation, cleaning validation and hold time validation.

11. Issuance of Hold time Validation, cleaning validation and Process Validation Protocol.

12. Any other work assigned by HOD.

Job Description : ( Qualification )

1. Qualification of Equipment / system such as HVAC System, Autoclave, Bung Processor, Powder Filling and Sealing machine, Vial washing machine, Depyrogenation tunnel, Hot air oven, various Equipment.

1. To prepare, review and execute protocol and report of validation for critical manufacturing processes like hold time, process validation, cleaning validation and media fill including observation of the media fill vials / ampoules etc.

1. To Prepare, review and fill the IQ, OQ, PQ document of new Equipment / machine.

2. Develop, Implement, manage, audit and maintain GMP Quality system.

3. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc.

4. To review and check the QA SOPs and provide training before SOP implementation.

5. To review another department SOPs.

6. To review & approval of Master Documents like BMR, Protocols and Reports etc.

7. Approve and release the final products or reject defectives.

8. To Prepare SOPs, Protocol and Report related to all Qualification and Validation studies.

9. Monitoring during calibration of various instruments.

10. Follow the Qualification schedule to plan, execute and documentation.

11. Performing the Temperature mapping activity of Manufacturing and staging area, Row Material storage area, Finished Goods area (NMT 25°C) and Cold Chamber (2°C to 8°C).

12. To perform the new equipment / machine qualification (IQ / OQ / PQ).

13. Prepared, review and filled the IQ, OQ, PQ document of new Equipment / machine.

14. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc.

15. Understand customer needs and requirements to develop effective quality processes

16. Responsible to maintain the plant hygiene.

17. Vendor audit to the site for raw material and packing material supply, site evaluation, audit report preparation, vendor documents pack verification and final approval to include vendor in approved vendor list.

Must Exposure in Parenteral Background

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