5+

Train and develop the scientific knowledge, selling skill and performance orientation for large field force of Cardio and Diabetic division.

Environmental and Microbial Monitoring, including compressed gases and microbial limit testing, qualification, requalification, aseptic techniques, documentation etc.

Well versed with Analytical methods validation/Method transfer/Cleaning validation, Handling HPLC, GC, DR and other instruments, Reviewing analytical data. Preparation of Validation protocols and reports.

Filling & Sealing, Lyophilizer, Visual inspection, Autoclave, Vial Washing, QMS, Audits &. Compliance.

Capable to handle analytical method development, Implementation, Validation as per requirement. Should have experience of Analytical method transfer to QC.

Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets

Clinical batch data review, method validation, and stability study evaluations as per cGMP & regulatory norms. Routine analysis of clinical samples and stability samples. 

Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.

Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.