Senior Quality Specialist


Vrouw in labo

Over deze funtie

  • Markt: Life Sciences
  • Branche: Pharmacie
  • Expertisegebied: Studie & Wetenschap
  • Standplaats: Antwerpen

Wat is vereist?

  • Uren per week: 40
  • Opleidingsniveau: Academic Master
  • Sluitingsdatum: zaterdag 26 juni 2021

Over deze functie

  • Maintain and adjust the electronic Quality Management System, alongside its current ongoing implementation. Identify problems and provide solutions for resolution. Determine system improvements for both compliance to ISO 13485 & 21CFR 820 and overall performance.
  • Setup of the procedures, instructions, and trainings for implementation of the different QMS modules and provide training to key users.
  • Handling of complaints and deviations (internal and external), including root cause analysis and subsequent CAPA handling.
  • Prepare and complete quality documentation and reports regarding quality, and customer-requirements by collecting, analyzing, and summarizing information and trends including failed processes, recalls, complaints and CAPAs.
  • Participate in risk management, both product and business oriented.
  • Participate in the Change control process, both Quality and other.
  • Assist in quality audits: audits from authorities and companies, internal audits, external audits with customers and inspections. Performs external audits at suppliers/subcontractor.
  • Promote quality awareness throughout the company. Train all staff concerning the Quality Management System and the use of Quality Management System.
  • Stimulate other departments to optimize processes and documents and help where possible.
  • Assist in implementing quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations.
  • Maintain proper communications with other departments to ensure communication and good relationships in connection with matters related to the quality management system.
  • Close cooperation with Regulatory and R&D departments to ensure QMS alignment concerning submissions, design dossiers, technical files and other regulatory and R&D documents.

Over jou

  • A minimum of 5 years successful working experience in a quality department
  • Knowledge/Experience of quality processes and procedures
  • Knowledge of applicable GxP ; 21 CFR 820 and ISO 13485
  • Fluency in English; both written and spoken
  • Analytical thinking & problem-solving capability
  • Hands-on – Initiative taking

Wat wij je bieden

Our network and expertise make it possible for us to advance your career. Brunel has a reputation of working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Start je sollicitatie hier!

Solliciteren bij Brunel gaat snel en gemakkelijk. Wij ontvangen graag het volgende van jou:

  • Recent CV of LinkedIn-profiel
  • Motivatiebrief (optioneel)
  • Certificaten (optioneel)
  • Referenties (optioneel)

Vragen over de vacature?

Jouw Talent Hunter, Elke Binst licht graag alles toe over deze vacature. Wanneer je contact opneemt, verwijs naar het volgende vacaturenummer:

Talent Hunter

Elke Binst
Brunel Belgium Mechelen

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