Multiple vacancies in AKUMS DRUGS & PHARMACEUTICALS | Require B.Pharm, M.Pharm, B.Sc, M.Sc in DRA, QA, AR&D, FR&D, IPR, stores and more
1.Individually handle the projects.
2.Analysis of Routine and stability samples.
3.Guide to juniors.
4.Interpretation of Stability study results.
6.Compilation of results.
7.Literature search for new projects.
8.Active participation in solving the regulatory queries
9.Responsible for Analytical method development of various dosage forms, solubility studies, Analytical Method Validation, Analytical Method Transfer etc.
10.Handling of deficiency letter queried by US FDA.
11.Preparation & Review of documents like SOPs, STPs for Raw materials, In-process and Finished products, AMVP and AMVR, Analytical method transfer protocols and reports, Study protocols and reports.
12.Should have thorough knowledge on ICH guidelines, USP, EP & BP.
13.IQ, OQ, PQ for new instruments
14.Calibration of Instruments and Equipments and review of reports.
15.Validation of Excel sheets.
M.Sc in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
4 to 6 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).
Exp: 1-6 years
Education: M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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