Officer - Quality Control

Posted 5 Days Ago
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Rupnagar, Punjab, IND
In-Office
Senior level
Biotech • Pharmaceutical • Chemical • Manufacturing
The Role
Perform wet and instrumental analysis of raw, in-process, finished and stability samples; execute method development/validation, HPLC calibration, stability studies, inventory and log management, record of analysis, deviation reporting and CAPA, troubleshooting instruments, and ensure cGMP/GLP/ICH/USFDA/ISO compliance and lab safety.
Summary Generated by Built In

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.
  • Skills Required

    • Post-Graduation in Chemistry.
    • Knowledge of cGMP and GLP guidelines, ICH and USFDA guidelines.
    • Working knowledge of method development and validation.
    • Experience handling instruments such as HPLC, GC, GCHS, spectrophotometer.
    • Minimum 6 years of experience in pharmaceutical industry with extensive QC experience in API manufacturing.
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    The Company
    0 Employees

    What We Do

    Centrient Pharmaceuticals is a global business-to-business manufacturer of foundational medicines, including antibiotics, next-generation statins, and anti-fungals. The company leverages proprietary enzymatic biotechnology to produce active pharmaceutical ingredients (APIs), intermediates, and finished dosage forms (FDFs). Headquartered in the Netherlands, Centrient focuses on sustainable, quality-driven manufacturing and supply chain security, serving as a key partner in the global healthcare system to improve patient lives through innovative medicine production.

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