Analytical method validation of different methodology. Dissolution Method Development and validation. Validation and method development protocol and report preparation.
Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control.
Formulation development of Injectable including development, execution, filing and approval of Complex Injectables viz. Liposomes, Peptides, long acting emulsions, suspensions, in-situ gels, Lyophilised injectable etc.
Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad. The company manufactures finished dosage formulations active pharmaceutical ingredients and crop health science products, and also provides contract manufacturing services.
Basic Microbiology, Media preparation, Autoclave, Gram staining, Anti microbial tests etc. GPT, BET, VITEK, Bl ENUMERATION, Bio burden. HPLC Analysis. Handling of UV, Elisa Technique, Stability study.
Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC,KF, IR,UV instrument. To review analytical data & handling of QMS i.e. Deviations, 00S, 00T, Laboratory incidences, OOC, CAPA and Effectiveness of CAPA.
Monitor and supervise production process to ensure compliance with SOP and cGMP. Maintain documentation as per regulatory authorities requirement like change control, deviations. Highlight technical problems and take corrective actions.
Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science. Understanding of medical practices regarding procedures, medications, and treatment for different disease states.
interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.