Centrient Pharmaceuticals

Officer - Quality Control

Centrient Pharmaceuticals  •  State of Punjab, IN (Onsite)  •  4 hours ago
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Job 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.
  • Centrient Pharmaceuticals

    About Centrient Pharmaceuticals

    Centrient Pharmaceuticals is the global business-to-business leader in sustainable, enzymatic antibiotics, next generation statins and anti-fungals. We produce and sell intermediates and active pharmaceutical ingredients (APIs), as well as our own tablets, capsules and other finished dosage forms (FDFs).

    We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 1,800 employees work continuously to meet our customers’ needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

    Founded 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is owned by Bain Capital Private Equity, a leading global private investment firm.

    Industry
    Chemicals & Materials
    Company Size
    501-1,000 employees
    Headquarters
    Rotterdam, NL
    Year Founded
    1869
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