Post Graduate Degree Life Sciences from a recognized institution, university with two years experience in R&D, Academic, Science and Technology Institutions after obtaining essential qualification.
As part of the Infosys consulting team, your primary role would be to get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight.
M.Sc. in the field of Biology, Molecular Biology, Human Genetics, Cell Biology, Biochemistry, Microbiology. Candidates with UGC-CSIR, NET, GATE, ICMR-JRF, DBT-BET qualification will be preferred.
The position will be working in a matrix organization with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to enable the preparedness of the employees to work on different projects and roles, to facilitate communication within the matrix organization, to ensure efficient and scalable resourcing supporting the business priorities.
Coordinate with cross functional teams e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
Single use systems or other process materials used during pharmaceutical or biopharmaceutical manufacturing, e.g. filter systems, tubing, connectors, storage bags, seals, and membranes.
Candidate should be well versed with the regulatory guidelines. Candidate should have shop floor experience of In-process control involving Non sterile and sterile operations.
Interpret and compile external supplier APQR and or extracted data from Internal Sandoz systems into a pre-defined template and draft conclusion of product quality review.
PhD in Pharmaceutics, Pharmacology, Nanotechnology, Biotechnology with experience in nanoformulations. Those who have submitted the PhD thesis may also apply.