IPQA - Drug Substance - Senior Executive/Assistant Manager

Biological E; Thumukunta; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Biological E is seeking professionals to ensure GMP compliance on the shop floor for bulk manufacturing. The role involves line clearance, BPR reviews, and maintaining Master/Working cell banks and virus seed banks with proper documentation.

You will support batch release, coordinate cross-functional teams, compile APR data, handle deviations and CAPA, and assist in process and cleaning validations along with maintenance and safety adherence on site.

Responsibilities

• 1. Ensure compliance of GMP in shop floor for bulk manufacturing areas
• 2. To ensure/ perform routine line clearance and in-process checks as defined in the BPRs during manufacturing activities.
• 3. Review of BPR for bulk manufacturing, trend reports pertinent to water, environmental monitoring and other utilities.
• 4. Issuance and reconciliation of Master/ Working cell banks and Virus Seed banks and maintenance of relevant documentation.
• 5. Ensure right first time in closure of executed batch production records.
• 6. Preparation, execution and review of equipment qualification activities pertinent to these areas, i.e Protocols, execution and closure reports.
• 7. Support timely batch release by closing Batch production records and associated QMS elements.
• 8. Coordination with cross functional team members and to ensure the submission of retention/ reference/ stability samples and others samples (as applicable).
• 9. Compilation of information for Annual Product review (APR) and preparation of report.
• 10. Review of equipment breakdown request
• 11. Handling of Deviation, Change control, CAPA and Risk assessments.
• 12. Support in preparation / review of Process validation, Cleaning validation, Change over and Media simulation protocol, reports and monitoring /ensuring the activities performed as per the protocol.
• 13. Coordination with cross functional team members and to ensure Preventive maintenance, Calibration, EMP and water sampling performed as per the defined schedules
• 14. Follow safety practices implemented at site and ensure adherence to them.

Job description

1. Ensure compliance of GMP in shop floor for bulk manufacturing areas

2. To ensure/ perform routine line clearance and in-process checks as defined in the BPRs during manufacturing activities.

3. Review of BPR for bulk manufacturing, trend reports pertinent to water, environmental monitoring and other utilities.

4. Issuance and reconciliation of Master/ Working cell banks and Virus Seed banks and maintenance of relevant documentation.

5. Ensure right first time in closure of executed batch production records.

6. Preparation, execution and review of equipment qualification activities pertinent to these areas, i.e Protocols, execution and closure reports.

7. Support timely batch release by closing Batch production records and associated QMS elements.

8. Coordination with cross functional team members and to ensure the submission of retention/ reference/ stability samples and others samples (as applicable).

9. Compilation of information for Annual Product review (APR) and preparation of report.

10. Review of equipment breakdown request

11. Handling of Deviation, Change control, CAPA and Risk assessments.

12. Support in preparation / review of Process validation, Cleaning validation, Change over and Media simulation protocol, reports and monitoring /ensuring the activities performed as per the protocol.

13. Coordination with cross functional team members and to ensure Preventive maintenance, Calibration, EMP and water sampling performed as per the defined schedules

14. Follow safety practices implemented at site and ensure adherence to them.