Job Description

Department Details
Role Summary
1. To review and approve executed batch records and checklists after verifying for compliance
2. To prepare and review BMR review reports and report any trends
3. Prepare Quarterly reports and present to Production & QA HOD
4. Ensure to review and approve risk assessments report, identify risks, actions to reduce/eliminate the risk
5. Responsible for coordinating quality risk assessment across various functions and departments
6. Prepare, review and approve SOPs by reviewing the contents for cGMP and regulatory compliance
7. Escalation of Quality events (Critical and Data integrity) to site QA head for further actions.
8. To follow GDP and to ensure GDP are followed in all documents during review, approval and closure
9. To compile data for monthly review meetings
10. To ensure updation of contextual review documents to facilitate batch release
11. Review the master batch records and executed batch records (BMR and checklists).
12 Perform line clearance and routing shop floor surveillance activities
13 Participate in investigations related to process, equipment.
14 Review the SOPs related to equipment operations, process support activities.
15.Monitor the product manufacturing, audit trail and perform the verification of product dispatch activities
Key Responsibilities
1. To review and approve executed batch records and checklists after verifying for compliance
2. To prepare and review BMR review reports and report any trends
3. Prepare Quarterly reports and present to Production & QA HOD
4. Ensure to review and approve risk assessments report, identify risks, actions to reduce/eliminate the risk
5. Responsible for coordinating quality risk assessment across various functions and departments
6. Prepare, review and approve SOPs by reviewing the contents for cGMP and regulatory compliance
7. Escalation of Quality events (Critical and Data integrity) to site QA head for further actions.
8. To follow GDP and to ensure GDP are followed in all documents during review, approval and closure
9. To compile data for monthly review meetings
10. To ensure updation of contextual review documents to facilitate batch release
11. Review the master batch records and executed batch records (BMR and checklists).
12 Perform line clearance and routing shop floor surveillance activities
13 Participate in investigations related to process, equipment.
14 Review the SOPs related to equipment operations, process support activities.
15.Monitor the product manufacturing, audit trail and perform the verification of product dispatch activities
Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 2 - 5 years