QA Validation

Department
- SIKKIM QA II
- Job posted on
- Jul 25, 2023
- Employment type
- P-P8-Probationer-HO Executive

1. Coordinating to Preparation and execution, Installation Qualification / Operational Qualification / Performance Qualification Protocols for new Utility (HVAC, Compressed Air & Water System) System and Requalification protocols for new/existing Utility System of the site & Equipment Qualification. 2. Coordinating to Preparation and execution, Installation Qualification / Operational Qualification / Performance Qualification Protocols for new/existing Software (SAP) System and Requalification protocols for new/existing Software System of the site. 3. Reviewing SOPs related to Qualification function. 4. Coordinating to initiation of change control, Deviation and CAPA as and when required in all aspects of qualification and responsible for closure of the same. 5. Ensuring the Implementation of cGMP in all aspects of qualification. 6. Identifying training needs and organizing training interventions to meet quality standards in all aspects of qualification activity. 7. Responsible for Checked By/ Reviewed By signatory on Batch Manufacturing Records. 8. Preparation and review of cleaning validation protocol, report and matrix. 9. Responsible for preparation, review and execution of hold time study protocol & report. 10. In process checking of validation batches. 11. Review of process validation protocol and summary report. 12. In process/ finished product sampling of validation batches as per approved protocol. 13. To ensure Technology transfer for new products from R&D to Site and Site to Site. 14. To conduct SOP/On Job trainings. 15. To follow cGMP, data integrity norms and adhere with company policy. 16. Monitoring risk management activities in all aspects of qualifications. 17. Other responsibilities assigned by seniors as and when required.