QA Specialist – Development – Exothera

Based in Jumet you will join a collaborative team full of passionate change-maker and you will strengthen the QA Operations Team. This position reports directly to the Head of QA Operations.

TASKS and RESPONSIBILITIES

  • Co-Establish, implement, maintain and continuously improve the specific quality management system for the product development activities by setting standards and ensuring continuous improvement of the activities
  • Evaluate and improve the current processes and provide training when necessary.
  • Maintain development, product, and processes quality in line with their development phases (Proof of concept to pre-clinical stages)
  • Review development-related documentation such as development plans and reports, participate in project meetings, etc.
  • Review and approve development and lab support related procedures and working instructions
  • Lead, coach, and develop operational partners in the organization on the quality requirements for the development of pharmaceutical products
  • Lead and contribute to corporate QA and QMS projects
  • Disseminate and promote a quality mindset throughout the organization and develop quality tools to support a quality culture
  • Perform supplier audits and certifications within the pharmaceutical development area
  • Participate in health authority inspections and/or customer audits and ensure appropriate quality actions are being developed.

REQUIREMENTS and QUALIFICATIONS

  • MSc in Life Sciences, Bio-Engineering or related field
  • At least 5 years in pharma/biotech environment, development of (bio)pharmaceutical processes is considered an asset
  • Technical writing skills
  • Experience in setting up a quality system is considered an asset.
  • Experience with inspections, audits, and certifications
  • Strong in communication and team player with excellent influential skills
  • Ability to work in fast-paced environments and to combine helicopter view and tactical actions
  • Fluent in French and English 

OFFER

We offer a long-term contract (CDI), a competitive salary, a complete compensation & benefits package, and the possibility of evolution in an international, dynamic, and fast-growing company.

Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now!

Let's work together to make biologics available and affordable for all!