Executive - Microbiology

1. Implement a system to have a smooth functioning of the microbiology department.
2. Serving as the primary point of contact to the Quality Control, Engineering and Production leadership to support batch manufacturing, deviation investigation, batch review and release for samples.
3. Maintaining the turn around time as per the agreed timelines for testing and releasing the samples.
4. Improve technical capabilities and quality practices within the department.
5. Supervise, mentor, and provide necessary training for development of Microbiology staff.
6. Lead the execution, completion and review of manufacturing documentation including batch production records, quality system documents and reports.
7. Serves as subject matter expert in multidisciplinary project teams and/or sub-team meetings within the company or with clients during product or method transfer (if any).
8. Providing technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved economics and process robustness.
9. Supporting deviation investigations and identifying CAPAs to resolve manufacturing related issues.
10. Contributing to and supporting lab organization, improving lab efficiencies, and reducing costs.
11. Collaborating with Quality control, Engineering and Production leadership in developing project plans and schedules and ensuring the tasks are executed accordingly to the specific campaign requirements and/or commitments.
12. Accountable for review of standard operating procedure related to microbiology testing, equipment operational etc.
13. Responsible for up to date the laboratory and maintained as per CGMP compliance.
14. Accountable for continuous improvement in the laboratory testing and compliance.
15. Accountable for compliance with the Quality management system i.e. Change control, incident, CAPA etc during the laboratory operation.
16. Ensuring that all microbial related trends reports are closed on time and inform the senior management for any untoward trend/ suggest appropriate CAPAs.
17. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.
18. Shall be responsible for microbiology laboratory operational control excellence by optimizing lab processes to achieve maximum efficiency
19. Shall be accountable for timely completion of SOP and CGMP training.

Minimum 6 years experience in a similar position

University degree in Microbiology

Microbiology