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    Quality Control Analyst - Haarlem, Nederland - Teva Pharmaceuticals

    Teva Pharmaceuticals
    Teva Pharmaceuticals Haarlem, Nederland

    1 week geleden

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    Beschrijving

    The opportunity

    As a Quality Control Analyst, you'll be responsible for ensuring the quality and compliance of our pharmaceutical products. Your key duties will include conducting detailed analyses, implementing new/updating test methods, and ensuring adherence to national and international quality standards such as cGXP, pharmacopoeia guidelines, and Teva Global standards.
    Next to that you will identify deviations, investigate root causes, and proposing corrective actions to uphold product quality and regulatory compliance.
    Will you be part of our Compliance, Stability and Investigations team?

    How you'll spend your day

  • Execute the implementation of and compliance with national and international quality standards (cGXP), pharmacopoeial guidelines and Teva Global standards Timely implementation of validated Analytical methods. Execute the review and implementation of Teva standards and procedures at the department. Maintain adherence to corporate policies and appropriate regulations through actions and decisions. Initiates corrective action as soon as deficiency is identified; completes checklist and other information sheets required and coordinates on-site inspection of sections for which responsible.
  • Write assessments, study protocols and reports as part of failure investigations or method updates, validations and/or verifications.
  • Testing and evaluation of quality of active ingredients and drug products throughout manufacturing process and during shelf life of the drug product (stability testing).
  • Maintain quality at the lab in accordance with site SOP's, regulatory guidelines and cGXP compliance requirements.
  • Participate in the change controlled quality management system for changes, deviations and out of specification results.
  • Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
  • Execute all work according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.
  • Preparation of documents that report the results of own lab work.
  • Give support during regulatory and compliance audits.

    • Your experience and qualifications

  • HLO+ (Bachelor's degree) in chemistry with several years of experience in a similar position in the pharmaceutical industry.
  • A strong analytical oriented mindset.
  • A minimum of 3 years of experience with chemical analysis techniques such as liquid and gas chromatography, particle size testing and water content testing in a cGXP environment.
  • Knowledge of and familiarity with relevant regulatory guidance's such as: Appropriate ICH Guidelines. Regulatory Agency/lndustry guidance's and Pharmacopeia Guidance's and Requirements including local regulatory requirements.
  • A good knowledge of chromatographic and other instruments operation and techniques.
  • Experience in analytical method development and validation.
  • Knowledge of Pharmaceutical quality systems (Trackwise).
  • Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA.
  • Ability to collaborate with in- and external team to manage a successful inspection and provide timely and thorough responses to the regulatory authority.
  • Experience in protocol and report writing.
  • Good knowledge of English language (verbal and in writing) is mandatory.
  • Good knowledge of Dutch language (verbal and in writing) is preferred.
  • Strong can-do mentality.
  • Result oriented team player.

    • Contact person

    Ivo Huijskens - Senior Recruiter Benelux & Nordics

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