Job Properties
  • Job Type
    Full-time Position
  • Background
    Medical and Healthcare
  • Languages
    English
  • Experience Required
    3 - 5 Years
  • Degree Required
    Bachelor
    • Province
      Baarle-Nassau
    • Date Posted
      November 10,2020
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    QA Operations Manager / QP

    AAA Statement

    Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
    AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

    Job Description

    The Quality Operations Manager / QP assures that all batches are released according to registered specifications. The function assures that the quality system of the site complies with regulatory and GMP compliance requirements as described by authorities and by AAA/Novartis internal guidelines and quality manual. The QA Operations Manager also acts as the site’s Lead Qualified Person.

    Major Activities:
    • Provide leadership to the team of QA officers and QP’s
    • Define resource needs related to the QA operations team. Ensure your team members are open to development and define training needs.
    • Guarantee the compliance of the local quality system to the GMP requirements and corporate standards;
    • Lead batch release activities and QP certification of the batches
    • Review, define updates and, approve of all the site specific quality system procedures;
    • Assure that people are trained on time and track additional training needs. Provide input to training needs and assure that the site associates have appropriate GMP training.
    • Provide input to the site master plan and quality plan of the site
    • Lead the review of maintenance, qualification, calibration and (re)validation programs at local level;
    • Review and approval at site level of OOS/OOT, deviations and complaints
    • Ensure the implementation of a supplier approval and review process and support auditing of suppliers and subcontractors
    • Support inspections by Health authorities and Novartis internal audits. Assure that related CAPA’s are implemented on time
    • Draft the annual product review (APQR) and propose CAPA’s. Assures that relevant quality topics are covered in periodic quality reviews.
    • Coordinate the self-inspections as per approved annual plan
    • Ensure that all the variations to the Marketing Authorization of an AAA product are implemented at local level;
    • Support escalation of Quality/cGMP issues and deficiencies to the Site QA Head and support global escalation process if needed.
    • Support associates within the AAA and Novartis network in case of Health Authority Notifications (s.a. FAR, Rapid alert, recalls)
    • Ensure at local level QA coverage during launches

    Minimum requirements

    Education:
    Scientific Degree, being able to act as QP according to local regulations

    Language:
    Dutch and English

    Experience/Skills:
     At least 3 years of experience in a pharmaceutical quality department (QA or QC). Approximately 3 year’s of manufacturing experience in a pharmaceutical environment, preferably in aseptic processing is recommended.
     Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills 
    Good knowledge of regulatory requirements and cGMP
     Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system

    Division

    Oncology

    Business Unit

    ADVANCED ACCELERATOR APPLICATIONS

    Country

    Netherlands

    Work Location

    Baarle-Nassau

    Company/Legal Entity

    IDB Holland bv

    Functional Area

    Quality

    Job Type

    Full Time

    Employment Type

    Regular

    Shift Work

    No
     
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