Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials.
Performs testing not only of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records. Carry out checks of record documentation.
Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
Develop stability study designs for new product development and sustaining product projects. Contribute to technical feasibility analysis of complex research and design concepts. Evaluate results relative to product requirements, definitions and/or program goals.
Postgraduate degree in Science/ Pharmacology/ Life Sciences/ Regulatory Science/ Public Health from a recognised University with atleast 6 years of relevant work experience
BRIC-Institute of Life Sciences (ILS), Bhubaneswar, an autonomous Institute of the Department of Biotechnology, Ministry of Science & Technology, Government of India, engaged in advanced research, invites applications from Indian nationals