QA Operations Manager Benelux EnglishFrenchEnglishFrench
GSK
Wavre, Belgium
5 dagen geleden

Your Responsibilities : Job Purpose :

Job Purpose :

  • The job holder will be member of the QA team within the GSK Consumer Healthcare Benelux Local Operating Company.
  • The jobholder will supervise the Benelux QA Operational activities related to batch release, complaint handling, product return handling and repacking.
  • The jobholder provides support to the implementation and maintenance of the Benelux Quality Management System.
  • Key Responsibilities :

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

  • Support Distribution Risk Assessments (DRA) for products supplied from manufacturing site to local warehouse and products supplied from local warehouse to end customer.
  • Ensure that any local Logistic Service Provider (LSP) is monitored, audited, a Quality Agreement is in place and that they hold the required authorisations and GxP-certificates.
  • Act as deputy Qualified Person (GMP) and Responsible Person (GDP).
  • Receipt, Storage and Returns - 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 - Lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.
  • Act as deputy of the Qualified Person (GMP) to QP-certify and release medicinal product batches to the market, in absence of the QP.
  • Oversee as Responsible Person (GDP) the GDP administrative release’ process of QP-released batches of medicinal products.
  • Ensure resolution of Quality-related issues arising from the deliveries.
  • Local Repacking. Manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity.
  • Perform local review of annual Periodic Product Reviews (PPR’s).
  • Recall & Incident management. Member of the local LIC Team as appropriate.
  • Support and / or perform Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS, GMP and GDP-requirements.
  • Provide training to Benelux associates in terms of basic GxP-requirements, and QA processes such as quality complaint handling and batch release.
  • Ensure oversight on the product quality complaint management process and follow-up with QA Specialist.
  • Supervise the management of products returned from the market and approve any returns to saleable stock as RP.
  • Support the QA team with the development and maintenance of procedures and work instructions.
  • Assist in the GxP-inspection readiness process and provide support during audits and inspections of the Benelux organisation.
  • Manage Change Controls by initiation, follow-up and action plan execution.
  • Facilitate local deviation investigations (Root Cause Analysis) and CAPA determination and execution. Record and perform follow-up in Carisma3 / QWF.
  • Contribute to the NE Area Quality Plan and ensure that agreed actions are locally executed.
  • Act as Subject Matter Expert for specific Benelux GxP-processes and systems.
  • Support management reviews and KPI-reporting.
  • Basic qualifications :

  • 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.
  • Strong general computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook
  • Able to work effectively in English, French and / or Dutch
  • Preferred qualifications :

  • 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
  • Ability to self-motivate and be resilient and focused under pressure
  • Why GSK? : Our Company :

    Our Company :

    GSK is one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

    GSK Consumer Healthcare produces a range of consumer health products based on scientific innovation. They develop and market a range of products in the areas of : Pain Relief, Respiratory, Oral Health, Nutrition / Gastro Intestinal and Skin Health.

    These include a number of well-known brands such as Sensodyne, Paradontax, Poligrip, Voltaren, Panadol, Otrivin and Theraflu.

    For further information, please visit www.gsk.com.

    Our Offer :

    At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

    GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.

    GSK is an equal opportunity employer.

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