Senior Manager, Analytical - Extractable & Leachable studies

☞ PAR FORMULATIONS PRIVATE LIMITED

Vue: 106

Jour de mise à jour: 06-05-2024

Localisation: Mumbai Maharashtra

Catégorie: Pharmaceutique / Chimique / Biotechnologie Santé / soins médicaux Pharmacien / Représentants pharmaceutiques

Industrie: Pharmaceutical & Life Sciences

Niveau: Bio-Technical Research Manager

Type d’emploi: Full Time, Permanent

Expérience: 12 - 20 years

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le contenu du travail

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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Date limite: 20-06-2024

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