Oversee the timely order and shipment of comparative samples from various suppliers to partners and Clinical Research Centres (CROs) globally to assist in bioequivalence studies.
Responsible for release of the product by ensuring review of relevant audit trial of Manufacturing. Strong knowledge of cGMP, ICH guidelines, FDA regulations, and other relevant standards for biologics manufacturing.
Should have hands on experience in Water samples analysis, In-process Bioburden and BET analysis, MLT analysis of Raw material and packing material, Antibiotic assay by Microbial method.