水平: Associate

工作类型: Full-time

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工作内容

Description
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
We are excited to be recruiting for a dedicated Quality Assurance Associate/ Senior Associate to join our Central QA team based in our Nazareth, Belgium(close to Ghent) location.
At Perrigo, our QA function is an integral, valued part of our business! Without the important work undertaken by the team our leading self-care products such as Davitamon, Dermalex, Galenco, NiQuitin, XLS and Physiomer would not be so readily available to our consumers!
If you want to have a positive impact whilst working alongside brilliant people, then read on…
Responsibilities
  • Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group.
  • Be the QA representative within certain product categories and be responsible for all QA matters associated with these.
  • Agree Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
  • Assist with due diligence and integration of new product developments / new product introductions for assigned categories.
  • Support technical transfers, qualification and validation work.
  • Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
  • Evaluate and follow-up Change Controls together with the Regulatory Affairs team.
  • Agree stability programs and review stability results.
  • Contribute to Supplier Qualification and Regular Supplier Auditing.
  • Occasionally provide QA training to the entire group regarding QA systems and processes and procedures and evaluate training effectiveness.
  • Maintain databases and documents according to good documentation practices and record retention procedure.
  • Support in the maintenance of the Quality Management System as SME.
  • Support the internal QA audits.
  • Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
  • Support QA in data and document collection for regulatory purposes.
  • Support QA in ensuring ongoing inspection readiness in your area of responsibilities.
Requirements
  • Masters’ Degree in pharmaceutical or biomedical sciences, engineering, biochemistry, chemistry, or other related subjects, or equivalent through experience.
  • A minimum of 3 years (associate) or 7 years (Sr. associate) relevant experience in Quality Assurance / Production.
  • Being approved as a Qualified Person (EU batch certification) is an asset
  • Knowledge of and experience in KB 14/12/2006, Directive 2001/83/EC and Eudralex Vol 4 and relevant pharmaceutical standards
  • Knowledge of manufacturing processes of solid, semi-solid and liquid formulations.
  • Knowledge of ISO 13485 and MDD/MDR is an asset
  • You speak and write fluently English. Other languages are an asset.
Why Join Perrigo?
  • Great work-life balance with a Hybrid work approach - 2 days onsite per week!
  • Fantastic team and supportive management to encourage professional development and growth!
  • Competitive Benefits & Compensation package!
  • The opportunity to have real business impact!
  • Opportunity to travel and enjoy our international scope!
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.
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最后期限: 31-12-2025

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