Roles & Responsibilities: 

1. Experience in process validation, cleaning validation and API production process.
2. Experience in equipment and utility qualification.
3. Preparation and Revision of MFR for all new existing products on changes.
4. Review of LMR & BPR for all new or existing products based on changes.
5. Experience in Quality management system e.g. Change control, deviation, market complaint and process technology transfer from R&D to production.
6. Candidate should be from USFDA, EDQM approved API organisation.