Manager - 2

Job Title:

Manager-2

Business Unit:

Sun Global Operations

Job Grade

G11B

Location:

Sikkim, Unit II

Sr. No. Responsibilities

1. To monitor all activity in QC department as per GLP.

2. To ensure the proper closing of OOS, Lab Incident, OOC & OOT, Batch Rejection (RM, PM, FP & Stability) on time.

3. To review the OOS, Lab Incident, OOC, OOT, Non conformities and ensure that the defined procedure as followed by QC to identify the root cause and establishment of CAPA.

4. To review the Log books/ Formats, Electronic & Paper raw data generated in QC lab as a secondary check by QA of QC.

5. To Prepare, review of trend of all laboratory errors and effective CAPA implementation to reduce laboratory errors.

6. To monitor that completion of Analyst Qualification prior to assign work to analyst.

7. Periodic review of Data Integrity and shop floor inspection of Lab as per predefined procedure.

8. To review and approve the Reduce Testing protocol as per SOP.

9. To Approve COA through LIMS for Batch release.

10. To Review CSV documents as process quality Lead

11. To Monitor all the document review related activity under analytical QA

12. To Approve LIMS audit trial for pending samples in monthly basis.

13. To review and Approve Message centre audit trial on daily basis.

14. Responsible for all aspects of quality assurance in quality control laboratories w.r.t. to assessment of quality issues in labs, review of documentation, compliance in QC labs, QC lab readiness for inspection, and contract testing lab management at the Site as per current Good Manufacturing Practices requirements

15. Maintain proper online implementation of SOPs/ CAPA and Preventive Maintenance through proper training

16. Ensure compliance of the functional area with company Health and Safety Policies.

17. Special Projects: Ensure support of special project through timely implementation in QA per project timelines.

18. Ensure people development initiatives and training are implemented within QA

19. Completion of individual training requirements with in timeline.

20. To ensure the audit compliance.

21. To review the change control of QC and ensure its closer and implementation verification

22. Preparation of Monthly data for laboratory error for CQA Reporting.

23. Execute assigned activities within established timeframe (# SOPs revised in a month, # SOPs revision pending beyond timeline).

24. Execute assigned activities correctly (first time right).

25. Ensure compliance against Internal/External audit observations

26. Support and maintain target on Global metrics related to QA: Compliance and Audit

27. Ensure proper online implementation of SOPs/ CAPA related to Internal Audit / other Audit and Preventive Maintenance through proper training.

28. Maintain inspectional readiness within the functional area: Maintain collaboration with QA and other department to ensure successful regulatory/customer inspection with no critical findings or repeat observation.

29. Ensure compliance of the functional area with company Health and Safety Policies

30. Any other work assigned by HOD.

Travel Estimate

Job Requirements

Educational Qualification

B. Pharm

Experience

Tenure: 12-15 years of experience in pharmaceutical industry.

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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).