QA Specialist - Development

작업 내용

Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus and viral vector production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. At Exothera and Univercells, our mission is to make health equally accessible to all.

Apply and be part of this great adventure!

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!