Centrient Pharmaceuticals

Executive - Quality Assurance

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

To ensure 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:

  • To participate in vendor qualification activities.
  • To participate in Internal/External audit activities
  • To ensure compliance as per applicable regulatory requirement.
  • Release/rejection of finished products, intermediates & raw material as per approval specification
  • Creation & release of Certificate of analysis.
  • Issuance and review of Batch production records.
  • QC analytical data review.
  • Handling sales return, recalls and compilation of APR data
  • To coordinate investigation of market complaints/deviation/OOS/OOT.
  • Log books management for various activities.
  • To ensure that sampling of all Finished products are done as per defined procedure and proper record is being kept compliance to cGMP practice.
  • To ensure compliance to all SHE guidelines and to ensure safe working.
  • Conducting monthly safety audit and ensuring the closures of observations.
  • Reporting of Near misses/Incidents.
  • Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work.
  • Clearance of safety work permits to ensure execution of activities in safe manner.
  • To release the Batches of Intermediates and Finish goods in SAP.

    • Requirements

    • Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
    • Knowledge of documentation related to quality and regulatory guidelines.
    • Minimum 9 years of experience in Pharmaceutical industry and extensive Quality Assurance 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
    Website
    centrient.com
    Social Media