Senior Manager, Analytical - Extractable & Leachable studies

☞ PAR FORMULATIONS PRIVATE LIMITED

Ver: 106

Dia de atualização: 06-05-2024

Localização: Mumbai Maharashtra

Categoria: Farmacêutico / Químico / Biotecnologia Saúde / Assistência Médica Farmacêutico / Representantes farmacêuticos

Indústria: Pharmaceutical & Life Sciences

Posição: Bio-Technical Research Manager

Tipo de empregos: Full Time, Permanent

Experiência: 12 - 20 years

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Conteúdo do emprego

Job Summary

Responsible for E&L study for Endo/ PAR sites.


Technical

  • Sound knowledge of Extractable & Leachable studies.
  • Good hands on experience, calibration & maintenance of Analytical instruments like LC-MS/MS, LC-MS, GC-MS, GC-MS- Head Space, HPLC, ICPMS, IR, UV, Ion chromatography, GC-FID, GC-ECD etc.
  • Good technical knowledge of finished product/stability/Raw material samples and execution of analytical method validation/verification study, instrument qualifications and calibrations.
  • Responsible for E&L study for Endo/ PAR sites.
  • To handle the internal & external audits effectively.

Documentation

  • Preparation of SOP, laboratory documents like method validation/ verification protocols & reports, SOPs, Standard Test Procedure & Specification.
  • Maintain good documentation practices.
  • Investigation of incident, deviation, OOS, and OOT during analysis to group leader.

Team support

  • Effective handling of team by identifying individual strength.
  • Coordination with Endo/PAR sites for method validation/ verification work
  • To upkeep laboratory for ATR.
  • To train the team for E&L study.

Knowledge

Good hands on experience, calibration & maintenance of Analytical instruments like LC-MS/MS, LC-MS, GC-MS, GC-MS- Head Space, HPLC, ICPMS, IR, UV, Ion chromatography. GC-FID, GC-ECD etc.


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Data limite: 20-06-2024

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