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Executive - Quality Assurance

Rupnagar, Punjab, India

25 Days 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.

    Qualification

    Master's Degree

    Job Overview

    Job Function: IT/Computers - Software & Software Services

    Job Type: Full Time

    Workplace Type: Not Specified

    Experience Level: Not Specified

    Salary: Competitive & Based on Experience

    Experience: 0 - yrs

    Contact Information

    Company about us:

    Centrient Pharmaceuticals is a global leader in sustainable, enzymatic antibiotics, next generation statins, and anti-fungals. For over 150 years, we have been at the forefront of modern healthcare, producing and selling intermediates and active pharmaceutical ingredients (APIs), as well as our own tablets, capsules, and other finished dosage forms (FDFs)....

    Company Name: Centrient Pharmaceuticals Netherlands

    Recruiting People: HR Department

    Website: http://www.centrient.com

    Headquarter: Rotterdam, South Holland, Netherlands

    Industry: Pharmaceutical / Clinical Research

    Company Size: 501-1000 Employees

    Location

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