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Executive / Senior Executive - Analytical Development
ConfidentialHyderabad / Secunderabad, Telangana19 days ago
Job descriptionTo perform analysis ensuring compliance with respect to GLP, GDP, cGMP and regulatory requirements. Perform the analytical test / methods as assigned by team lead / reporting manager. Preparation of Method Validation / Verification / Transfer protocols, reports and submit for review. Perform Analytical Method validations / verifications / Transfers as assigned by team lead / reporting manager. Perform calibration of different equipments as assigned by team lead / reporting manager. Follow the Standard Operating Procedures while operating the different instruments / equipments. Report any problems with tests, equipment or results to the immediate supervisor. Perform laboratory duties by receiving samples from other departments. Recording of analytical results in the appropriate Lab note books. Maintenance of chemicals / equipments as per the standard operating procedures. Procurement of laboratory chemicals / reagents / standards / columns. Ensure calibration of equipment before use and inform the supervisor as required. Keep lab work areas clean and organized. Initiate QMS elements like Change controls, Deviations, LIR and CAPA's pertaining to validation lab. Execution of experiments to address regulatory queries / deficiencies for dossier filings. Responsible for preparation of standard operating procedures. To participate in internal, customer and regulatory audits as and when required.
Skills Required
Sops, Method Validation, Qms, Regulatory Compliance, Calibration
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Senior Executive • Hyderabad / Secunderabad, Telangana
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