Method Development, Method Validation, Method Verification of DS, DP as per In -House and monograph methods. Testing of analytical samples by using HPLC, GC, Dissolution, AAS, Titrations, Wet analysis.
Pre formulation studies of Pharmaceutical & Medicinal Devices and to check the compatibility of the API with different excipients. Formulation development of Pharmaceutical & Medicinal Devices
Responsible for processing of Individual Case Safety Reports ICSRs from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable
Expertise in Nitrosamine and elemental impurities and recent regulatory updates. Handling of analytical instruments e.g. HPLC, UPLC, UV, KF, Particle Size, Dissolution, LCMS, GCMS, ICPMS and Zetasizer. Expertise in Analytical Method Development Assay/ RS/CU/ Dissolution and report writing.
Sets up product development and registration objectives in aligment with RA Sub-Region Head, RA MOW Head New Product Planning, Regional Commercial team objectives and in close partnership with the local LT. Master in Life Sciences degree. PhD or Higher Degree or equivalent experience desirable
Maintain information flow at the interfaces to internal parties like packaging materials management, transport management, quality department, procurement, serialization and AW. Manage the end to end execution cycle of a Purchase Order.
To prepare change control proposal and to initiate change control in SAP. To prepare the SOP as per approved change control and assign the trainings to concern persons as per TNI in Aspire LMS system. To initiate the incident/deviation/CAPA in SAP related to warehouse.
Established during the Swadeshi Movement of India, Biological E. Limited (BE) started during a time when the nation sought access to critical healthcare products. Founded and led by Dr. DVK Raju, Biological E. Limited commenced its operations in 1953 as a biological products company manufacturing liver extracts and anti-coagulants. With an objective of transitioning from treating diseases to preventing them, Biological E.