Analytical method validation of different methodology. Dissolution Method Development and validation. Validation and method development protocol and report preparation.
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.
Responsible for timely preparation of collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs. To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages, preparation of packaging and QC testing instructions and assigning periodic re-test intervals.
B.Pharma, Diploma in Pharmacy. B.Pharma with 03 years of relevant experience & Diploma in Pharmacy with 05 years of relevant experience in IP, OP Store. Pharmacy.
Performing the periodical system washing of HPLC systems related to method development group. Responsible for calibration of HPLC and UPLC, 1C and dissolution apparatus.