QA OFFICER

ZaventemIIndustrie pharmaceutique

Description de fonction

Reporting to a QA Manager, Provide day-to-day assistance for commercial QA activities associated with the effective running of the site QMS to support batch disposition activities with relation to the companies BREXIT preparations. The QA officer will ensure assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.

As an QA OFFICER you will be responsible for: 

  • Provide maintenance of quality systems primarily the creation of D declarations and associated electronic system changes to support BREXIT preparations
  • Supporting change management activities relating to BREXIT and site compliance activities
  • Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP
  • Support inspection readiness for BOH inspections and external vendor audits in relation to BREXIT changes
  • Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GMP standards
  • To compile & review Product quality review sets for completeness & compliance to EU GMP, Hospira internal requirements and regulatory dossier submissions
  • Project execution and support as required
Profil

Must haves:

  • Bachelor’s degree in a related scientific discipline with relevant experience (Preferably Biology / Chemistry/ Pharmacy/Life Sciences) or equivalent
  • Basic experience in pharmaceutical manufacturing or distribution
  • Experience in Quality administered systems. Previous use of Trackwise® QMS beneficial.
  • Experience in preparing or supporting
  • D declarations or variation submissions
  • · Experience in raising and management of change controls
  • · Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
  • Able to demonstrate good planning and organisation skills
  • Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).
  • Quality and process orientation and mindset
  • Possession of good verbal and written communication skills
  • Ability to accept responsibility and be

Nice to have:
  • Global manufacture and supply chains
  • New product launches & commercial supply chain
  • Regulatory variation submissions
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 project sourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced 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 Zaventem we are looking for a 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 Antwerpen +32 3 612 22 92
QA OFFICER Informations offres d'emploi
62607
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Project sourcing
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