QA Operations Manager – Delegate QP/RP
GSK
Wavre, Walloon Brabant, Belgium,
4 dagen geleden

As QA Operations Manager BeNeLux, you are a member of the QA team within the GSK Consumer Healthcare Benelux Local Operating Company.

You supervise the Benelux QA Operational activities related to batch release, complaint handling, product return handling and repacking and provide support to the implementation and maintenance of the Benelux Quality Management System.

Your responsibilities :

  • You act as liaison with GSK-sites and Contract Manufacturing Organizations (CMO) Quality for products that are manufactured, to ensure compliance to local registered technical details (in connection with local regulatory team).
  • You support Quality Lead with the review and approval of the Technical Terms of Supply (TTS) and Quality Agreements where needed.

  • You support Distribution Risk Assessments (DRA) for products supplied from manufacturing site to local warehouse and products supplied from local warehouse to end customer.
  • You ensure that any local Logistic Service Provider (LSP) is monitored, audited, a Quality Agreement is in place and that they hold the required authorizations and GxP-certificates.
  • You act as deputy Qualified Person (GMP) and Responsible Person (GDP).
  • Receipt, Storage and Returns - You ensure LOC processes and systems in place for all activities related to receipt of stored goods, receipt of returned goods, warehousing and storage of all products are in compliance with GSK QMS.
  • Batch Release to Market You lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.
  • You act as deputy of the Qualified Person (GMP) to QP-certify and release medicinal product batches to the market, in absence of the QP.

    You oversee as Responsible Person (GDP) the GDP administrative release’ process of QP-released batches of medicinal products.

    You ensure resolution of Quality-related issues arising from the deliveries.

  • Local Repacking : You manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity.
  • You perform local review of annual Periodic Product Reviews (PPR’s).
  • Recall & Incident management : you are a member of the local LIC Team as appropriate.
  • You support and / or perform Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS, GMP and GDP-requirements.
  • Why you?

    Basic Qualifications :

    We are looking for professionals with these required skills to achieve our goals :

  • Master in Pharmaceutical sciences or another related science
  • Min. 4 years of experience in the pharmaceutical industry, in a quality function.
  • Certified Industrial Pharmacist / Qualified Person.
  • Analytical mind, good attention to detail and problem-solving skills within a structured process
  • Good team player works well in cross-functional teams
  • Good time management skills, with ability to multi-task and work under pressure
  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
  • Able to work effectively in English, French and / or Dutch
  • Preferred Qualifications :

    If you have the following characteristics it would be a plus :

  • Ability to self-motivate and be resilient and focused under pressure
  • Strong general computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook
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