1. Preparation and Monitoring of Annual Production Budget
2. Implement the budgeted Production target and ensure compliance to Quality, Quantity and Timeliness.
3. Validation of Process and Critical equipments.
4. Monitor and Control of Manufacturing Operations and ensure safe operating practices.
5. Preparation and reviewing of the documents in line with standard procedures.
6. Ensure complete accountability of manufacturing teams.
7. Failure Root Cause Analysis and Submission of report to the Sr.Management.
8. Assist in Scale up Process Improvements developed at Process development Lab (PDL) and RND to Production Scale.
9. Compliance to both Internal and External Audits. Facility Upkeep for Visits.
10. Monthly Reports to Sr.Management.
11. Training and Development of the team members.
12. In the absence of the employees the above deliverables will be conducted by respective section heads of the API Biotech Manufacturing.
An M.Tech. Bio-Technology, with a minimum of 15 years Biotech API Manufacturing experience.
Must have faced at least one audit each of US FDA and EU Member State.
Must have excellent knowledge and working experience on latest regulatory happenings in the Bio Similar domain.