Job in AKUMS Drugs & Pharma | Require Trainee / Assistant Officer / Officer - QC, Manager QA, Research Scientist-AR&D, Executive in DRA, IPR, packaging development
AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 people. Akums is engaged in the manufacturing of tablets, capsules, injections, syrups on loan licensing and third party manufacturing basis. Akums is having certifications of WHO-GMP, ISO 9001, ISO14001:2004,NDA Uganda, PPB Kenya and complying USFDA , MHRA & other international standards.
Post: Trainee / Assistant Officer / Officer - QC, Manager QA, Research Scientist-AR&D, Executive in DRA, IPR, packaging development
Trainee / Assistant Officer / Officer - QC
M.Sc -Chemistry ./B.Pharm with 0-2 years experience in testing, documentation, validation and method development of pharmaceutical formulations/ injectables/ oral dosage/ ointment & cosmetics etc.
Well versed in handling sophisticated instruments such as HPLC, FTIR, TOC, GC is required. Different positions for different dosage forms.
Manager – Quality Assurance (cosmetics)
M.Pharma /M.Sc./Ph.D/ B. Pharma with 8-12 years experience in testing, documentation, validation and method development of cream, ointment lotion, shampoo in Pharma / Ayurvedic /Cosmetics.
Candidate should have worked with cream, ointment lotion, shampoo in Pharma / Ayurvedic /Cosmetics.
Ability to handle market complaints, change controls, deviations, OOS, Failure Investigation, Art work / correction on drug license etc.
Well exposure in validations, documentations, calibrations, microbiology, Aseptic practices exposure, annual product Review with Trend Analysis.
Yield reconciliation & Line Clearance & In process Quality Assurance checks in manufacturing Sections.
Should be able to work independently & can face national & International audits.
Should be well concern with GMP Rules & Regulations.
Individually handle the projects.
Analysis of Routine and stability samples.
Guide to juniors.
Interpretation of Stability study results.
Compilation of results.
Literature search for new projects
Active participation in solving the regulatory queries
Responsible for Analytical method development of various dosage forms, solubility studies, Analytical Method Validation, Analytical Method Transfer etc.
Handling of deficiency letter queried by US FDA.
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.
Should have thorough knowledge on ICH guidelines, USP, EP & BP.
IQ, OQ, PQ for new instruments
Calibration of Instruments and Equipments and review of reports.
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).
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