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Executive / Senior Executive - Analytical Development

3-8 Years
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  • Posted 4 days ago
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Job Description

  • To 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.

About Company

Biological E. Limited (BE), the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognised vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world. BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO, many global markets, and in India to the National Immunization Program, various State Governments, PSUs, Indian Armed Forces and the domestic retail market.

Over the last many decades, Biological E. Limited expanded its product portfolio to cover a whole range of pharmaceutical formulations targeting different therapeutic segments including Respiratory, Cough Management, Gastrointestinal, Nutraceuticals, Anti-Infective, Analgesics and Critical Care. In this journey Biological E has created many legacy brands that offer high-quality trusted solutions to the doctors to handle the most common health challenges the country faces. The wide reach of our sales and distribution team also ensures that these brands are available all across the country, be it the top metros or the remotest of the villages.

We use science based innovation for developing products to meet the specific needs of the end consumers. We focus on developing affordable, efficient and high quality products for acute therapies.

Job ID: 114030955

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