Job Description

Department Details

Role Summary

1
Overall QMS management for Site 1
2. To provide CAPA, follow up, implementation and harmonization of the audit findings in co-ordination with the end user (production, Engineering & Maintenance and maintenance and instrumentation)
3. Investigation of nonconformance of products and implementation of CAPA arising out of OOT, OOS, Deviations.
4. Preparation, implementation and training of general SOPs of production. Initiation of common change controls across the sites for harmonization of production procedures.
5. Documentation control/ implementation and control on good documentation practices.
6. Issue of quality documents for data entry and entering data in quality records.
7. Responsible for giving objectives and proper utilization of down the line production personnel.
Role 2 1. Adherence to Quality Policy and Quality Management System.
2. Adherence to Standard Operating Procedures, product specifications.
Role 3 SITE 1 - IFP SUPERVISOR (1100-SMALL MOLECULES-SMV BLR-17561)
Role 3 1. Adherence to Standard Operating Procedures, product specifications.
2. Monitoring and control of specific production operations, Product handling, product
3. identification and co-ordination activities with QC/QA/SCM.
4. Achieving the production targets.
5. Production, raw material planning in co-ordination with Supply chain management.
6. Maintenance of Production equipment in coordination with Engineering and maintenance Department. Maintenance of spares in coordination with Engineering and maintenance Department
7. Monitoring the process efficiencies.
8. Plant and Machinery modifications or Improvements. Providing resources for implementation related to the process.
9. Costing and Budgeting for Production Department.
10. Responsible for giving objectives and proper utilization of down the line production personnel.
11. Adherence to Good manufacturing practices.
12. Reporting of non-conformities and adherence to the corrective / preventive actions for OOT,OOS, Deviations.
13. Authorized to raise and review the Change Control and Deviation Reports.
14. Authorized to prepare, issue and review quality documents.
15. Imparting training to the below hierarchy level on SOP's, EOP's IOP's and process related aspects to maintain quality and consistency in Production.
16. To follow the established procedures and policies of the company pertaining to EHS management system.
17. To understand the implications of not following the defined procedures with respect to EHS.
18. To attend Safety Committee meetings.
19. To effectively participate in the preparation of AIM and HIRA register.
27. Overall coordination with other departments related to production activities.
28. Adherence to Quality Policy and Quality Management System.
29. To coordinate with QA for all the validation, qualification and Audit preparedness.

Key Responsibilities

Supervising fermentation activities at site 1 including QMS.

Educational Qualifications

Required Education Qualification: M.Sc
Required Experience: 10 - 15 years