Quality Control Manager

Quality Control Management

Candidate should be from Pharmaceuticals and API Industry Back ground.

1 Overall responsible for Dahej QC activities.

2 Ensuring the requirement of 21 CFR part 11 and implementation in the work area. Ensure contemporaneous entries as per procedure.

3 Coordination for analysis of incoming raw materials, packing materials, Intermediates, Finished products in coordination with all cross functional team.

4 Coordination for non-routine activities, calibration, and stability studies, method validation, in coordination with all cross functional team.

5 Investigation of the quality management system : Laboratory Incidents, Deviations, OOT & OOS

6 Customer complaints: Investigation of customer complaints to identify the root cause and CAPA. Implementation of CAPA .

7 Preparation and revision of QC SOPs, manuals and document issue control

8 Equipment qualification (Design, installation, operation and performance), preventive maintenance.

9 Review of the quality management system like cleaning, sampling, analyzing and documenting the process.

10 Review and approval of analytical report, calibration reports, qualification reports.

11 Entries in ERP as per requirements.

12 Coordinate with external laboratory and service provider.

13 Review of qualification documents (Design, installation, operation and performance), preventive maintenance documents, calibration documents and etc.

14 On job Training to the new chemist as per the training schedule provided by the HR department / Training department.

15 Participating in Internal audit and to complete the audit observation and compliance.

16 Compliance to internal audits & external audits related to Quality control laboratory.

17 Ensuring the analysis as per the specification.

18 All QMS documents are to be prepared and review, related with Quality Control department.

19 Review of certified reference standards and working standards documents and ensuring the validity.

21 Review of Specification and related documents in periodic basis and updating of the same where ever required.

22 Review and approval of calibration schedule, preventive maintenance schedule.

23 Ensuring the safety practices in the quality control area.

24 Departmental activities communication to CQO on daily basis.

25 Vendor development samples analysis and sharing the evaluation of samples to the purchase / QA.

26 Change control to be filled and submitted to QA for further assistance with proper justifications and documents.

27 Adherence to GMP, ensure that QC activities were carried out in line with laid down procedure.

28 Follow the EHS Aspects, policy and procedure.