Officer - Quality Control

Found in: Talent IN 2A C2 - 2 weeks ago

Rupnagar, India Centrient Pharmaceuticals Full time
Position Description :

Position ensures that the products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA/ISO guidelines.

Key Responsibilities:

  • Analysis of Finished products / raw materials/ in process & stability samples (Wet & Instrumental analysis)
  • Preparing stability trend and then sharing with all stake holders
  • Conducting LSC to update all stake holders on stability status
  • Calibration of HPLCs as per defined procedure and schedule
  • Method validations as per applicable guidelines
  • Inventory management of reagents/columns spares etc. required for Premix analysis
  • Mobile phase preparation and their record keeping
  • Printing and preparation of record of analysis
  • Log books management for various activities
  • Preparation/Revision of method of analysis
  • Revision/Preparation of specifications in consultation with Purchase and other departments
  • Reporting of deviations in analysis as per LIR procedure and implementation of CAPA
  • Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments)
  • To ensure good housekeeping in the working area as well as in surroundings
  • Conducting of stability studies of Premix for validation batches/Annual batches
  • To ensure compliance to all SHE guidelines and to ensure safe working

Requirements

  • Post-Graduation in Chemistry
  • Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines
  • Working knowledge of Method development and validation
  • Handling of instruments like HPLC/GC/GCHS/Spectrophotometer etc
  • Minimum 6 years of experience in Pharmaceutical industry and extensive Quality control experience in API manufacturing industry

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