- Execution of Analytical method development and Method validation/ Method transfer.
- Follow all the safety rules and regulations in the premises that adhere to cGLP practices and procedures.
- Execution of various documentation related to Analytical Development functions
- Responsible for other functions related to Analytical Development assigned by the Group Leader.
- Preparation & Execution of Method validation/Method development, Method transfer, Material of contact study protocols, Feasibility study Protocols.
- Ensure Method transfer activities in adherence to cGMP/ cGLP systems and procedure.
- Maintaining/Coordinating amongst all internal & external customers. Ensure personnel safety in the work area.
- Calibration of various analytical instruments.
- Download, review and compilation of analytical method & reports, procedures for Raw materials, finished product, stability, packaging materials from originating sites.
- Generation of Working standards/Reference standards.
- Feasibility studies for raw materials and finished products.
- Analysis of in-process, finished, stability samples, MOC studies, Filter compatibility studies, etc.
Qualification & Experience:
- 3 to 8 years of experience in Analytical development functions in a reputed pharmaceutical Company dealing with regulated markets.