Senior Manager - Extractable and Leachables

1. Lead the Extractable and Leachable division of Fusion.

2. Design, Plan and Deliver Projects for Extractable and Leachable.

3. Evaluating feasibility for projects on MS i.e. LCMS, GCMS and ICP MS.

4. Evaluation will include Genotoxic Impurities, Nitrosamine Impurities, Elemental Impurities, Extractable Studies and Leachable Studies

5. Planning and Execution on day to day basis.

6. Co ordinate with team and clients to address timelines for projects.

7. Finalisation of Protocol, Analytical Method Development Reports, Analytical Method Validation Report, COAs, STP and other Analytical Documents related to MS.

8. Driving the Quality Management System (QMS) in Fusion along with the Quality Assurance Team for allocated projects and instruments.

9. Ensuring timely delivery of projects along with closure of QMS related documents.

10. Ensuring compliance with USFDA norms and face regulatory and client audits.

11. Participate in client meetings and ensure effective communication.

12. Contribute in preparing SOPs related to the Analytical Laboratory.