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Officer - Quality Control

Mumbai, MH
Job Code:
  • Retail & Wholesale
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Job Details

Job ResponsibilitiesPerform and document stability analyses and investigations on drug substance and drug product for various techniques (HPLC, Dissolution, Titiration, CE, etc) according to protocol, specifications, analytical methods and proceduresEnsure proper planning for execution of analysis within window so as to ensure first pass analysis avoiding human errors.Adequate knowledge on regulatory requirements for stability testingTo ensure immediate escalation of issues not in conformity with applicable procedures /policies etc.Results reporting into the LIMS or any other applicable systemMaintenance and qualification/calibration of lab equipmentTechnical/scientific support to other labs within the premisesParticipate in project teams as analytical technical team memberComply with the analyst responsibilities according to various proceduresTraining of colleaguesInitiate, document and coordinate deviations and events in applicable Event Tracking SystemImplement CAPAsCompilation of work instructions and standard operating proceduresInitiate applicable change requests according to the proceduresExecute the tasks according to the cGMP guidelines. Functional competencies (Skills, Knowledge and Attributes)Experience with sample analysis (Formulations and bulk drugs)Expertise with a variety of analytical techniques e.g. HPLC, GC, UPLC, dissolution, KF, DSC, etc.Exposure to empower software for HPLC data processing preferredExperience of working in a regulated
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 4-9


Quality Assurance | Quality Control | Statistical Quality Control | Total Quality Management
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