Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes
Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.
Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.
Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.
Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents. Writers and edits clinical regulatory documents, including submission summaries and other complex documents.