QA OFFICER

ElseneIIndustrie pharmaceutique

Description de fonction

As a QA OFFICER you will support the team with the maintenance of an appropriate and sustainable Quality Management System (QMS) or legal entities and Quality Culture at the company in order to ensure compliance with Regulatory Authority and client expectations.

Key areas falling within the scope for this function:

  • Product Quality System
    • Contribute in the deployment and maintenance of an effective and sustainable QMS.
    • Ensure timely implementation of all applicable global Product Quality Standard Operating Procedures (SOP), also referred to as Global SOPs (FSOP) and local SOPs within the PCO.
    • Ensure all relevant PCO colleagues are appropriately trained in applicable Product Quality SOPs.
    • Supervise all processes related to GDP (relabeling/repackaging, drug supply, stock management, stock availability, customer management, logistics complaint handling, temperature monitoring and transport of products, product disposal…) and GMP (relabeling/repackaging and pharmaceutical operations).
  • Deviation Management (in conjunction with the Quality operations of the company)
    • Investigate, together with appropriate local/global functions, deviations against Product Quality and/or Compliance requirements that occur within the responsibility of the PCO organization and agree and track preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeit, temperature excursion during transport or issues with contract manufacturers or logistics service providers etc.
  • Local Product Dispositioning
    • Local administrative release verification in compliance with the applicable local regulations and local procedures prior to distribution/sale within the market.
    • Evaluate which returns can be taken into consideration for return to saleable stock, supervise and support local actions, in cooperation with logistics and distribution center.
  • Product Complaint Handling
    • Support the process of compliant handling of product quality complaints.
  • Oversight of local Repackaging and relabeling operations
    • Ensure relabeling/repackaging contractor has been assessed and approved.
    • Review documentation related to the repackaging/relabeling operation and follow-up corrections if required.
    • Obtain regulatory approval of the repackaging/relabeling activity, if required under the local regulations.
    • Inform the releasing site of the repackaging/relabeling activity.
    • Release the repackaged/relabeled product prior to distribution/sale within country.
  • Development and maintenance of Consistent Quality Culture
    • Provide ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
  • Local Contractor Quality Oversight
    • Oversee quality operations at contractors, which includes but is not limited to:
      • Contractor Assessment and Approval: ensure all GMP/GDP contractors have been formally assessed and approved.
      • Deviation Management: evaluate the impact of all significant deviations affecting safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agree upon corrective actions. If necessary, initiate the “Notification to Management” process.
      • Quality System Support: visit the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM).
      • Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.

 

 

Profil
  • You have a Master or Bachelor degree in a scientific field (industrial pharmacist is a big plus). 
  • Preference 1-5 years of experience working in Pharmaceutical and related industries in a Quality Operations, Manufacturing or Regulatory role.
  • Previous working experience in GDP is an asset.
  • Assess risk and make sound and effective quality decisions under pressure through analysis of data.
  • You are diplomatic in communication with internal and external customers.
  • You show strong negotiation and effective communication skills.
  • You are a self-motivated individual who is comfortable with working independently.
  • You are able to work effectively in cross-functional teams & collaborate.
  • You move from an overall picture view to details and return again, as situations develop and need change (helicopter view and ability to prioritize).
  • Languages:
    • English verbal and written
    • French or Dutch verbal and written
Descriptif de l’organisation et du département

Select Projects is part of an international full-service Human Resources organization, Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, Netherlands and Dubai, we provide support to companies who need expercienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

For one of our pharma clients in Elsene we are looking for an QA OFFICER . 

Offre

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Avez-vous des questions?
Aartje Huybrechts Select Projects +32 3 612 22 92
QA OFFICER Informations offres d'emploi
68995
Sciences de la vie I Ingénierie - Projets
Project Sourcing
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