We are looking for QA executive with 4-5 years of experience in Vaccine QA.
Qualification- M.Sc. biotechnology/B Pharma
#qualityassurance #investigation #CAPA #Reviewer
#qualityassurance #investigation #CAPA #Reviewer
Job Description
1. To prepare and review master documents. (i.e. Site master file, Quality Manual, SOPs)
2. To log, evaluate and review investigation and closing of Deviations/Change Controls/CAPAs.
3. To participate in Market Complaint investigation. Review the investigation and response prepared.
4. Responsible and coordination for Product recall and Mock recall committee and compile the reports.
5. To prepare Annual Product Quality Review of the products and ensure compliance to SOP & regulatory requirements.
6. To ensure storage, maintenance and destruction of the Control Samples and periodic review.
7. To prepare and review trend analysis of QMS system with cause identified and recommend measures for reducing of reoccurrence.
8. To support & review required documents for filing by regulatory affairs team.
9. To impart QMS training
10. To prepare compliance index
11. To initiate alert notification to regulatory agency and critical quality event notification to management.
12. To handle QMS software like TrackWise, Documentum, LIMS, SAP, AmpleLogic.
1. To prepare and review master documents. (i.e. Site master file, Quality Manual, SOPs)
2. To log, evaluate and review investigation and closing of Deviations/Change Controls/CAPAs.
3. To participate in Market Complaint investigation. Review the investigation and response prepared.
4. Responsible and coordination for Product recall and Mock recall committee and compile the reports.
5. To prepare Annual Product Quality Review of the products and ensure compliance to SOP & regulatory requirements.
6. To ensure storage, maintenance and destruction of the Control Samples and periodic review.
7. To prepare and review trend analysis of QMS system with cause identified and recommend measures for reducing of reoccurrence.
8. To support & review required documents for filing by regulatory affairs team.
9. To impart QMS training
10. To prepare compliance index
11. To initiate alert notification to regulatory agency and critical quality event notification to management.
12. To handle QMS software like TrackWise, Documentum, LIMS, SAP, AmpleLogic.
Send your CV at rachana.narayan@zyduscadila.com
.jpeg)
.jpg)