QA Operations Manager

Il y a 2 mois

Brussels, Belgique Michael Page Temps plein

As the successful QA Operations Manager, you will have the following responsibilities:

  • Work with the Benelux Quality Lead to ensure compliance, product quality, audit/inspection management and readiness
  • Take the full ownership on the RP responsibilities - mainly focus on NL at first
  • Participate to the QP-certification of medicinal products.
  • Oversight and supervise the Benelux QA Specialists in the operational activities:
    • Batch Release dossier preparation
    • Receipt, Storage and Returns
    • Local Repacking
    • Quality Complaints management
  • Ensure oversight of Benelux Logistic Service Providers
  • Act as liaison with manufacturing sites and CMO
  • Participate with the Quality Lead to the supplier qualification activity and the review and approval of the Technical Terms of Supply and Quality Agreements.
  • Ensure an efficient customer verification process
  • Approve and follow up Benelux Change Controls
  • Perform local review of annual Periodic Product Reviews
  • Participate to the setup of Distribution Risk Assessments (DRA) for products supplied from the local warehouse to the end customers.
  • Ensure oversight and support Independent Business Monitoring and Self-Inspections in full compliance
  • Ensure local Quality deviation investigation (Root Cause Analysis), CAPA definition and execution.
  • Follow up the deviation and CAPA lead-times.
  • Integrate the local Product incident review Committee as appropriate and support of recall coordination when required.
  • Support the QA team with the development and maintenance of procedures and work instructions.
  • Act as Expert for specific Benelux GxP-processes and systems.
  • Participate to Quality Councils. Support management reviews and KPI-reporting.
  • Contribute to the Benelux Quality Plan (setup and execution).

As the successful QA Operations Manager, you will have the following requirements:

  • Certified Industrial Pharmacist / Qualified Person / Responsible Person
  • At least a Master degree in Pharmaceutical Sciences or related life science field
  • Good understanding of GDP and GMP, pharmaceutical regulation
    ,
  • A proven experience as a practising QP/RP
  • Analytical mind, good attention to detail and problem-solving skills within a structured process
  • Demonstrable time management skills and ability to multi-task in an ambiguous environment
  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
  • Self-motivated and resilient
  • Fluent in English & Dutch - French is consider as a strong asset

As the successful QA Operations Manager, you will:

  • Have an attractive complete salary package in line with your experience (Bonus, Net allowances, Company car, etc.)
  • Join a fast moving & growing environment where you will be part of the future of the organisation
  • Integrate a strong team driven by expertise & qualitative work
  • Have growing & personal development opportunities

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