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Location

Andover, Hampshire | United Kingdom

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Job description

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: “Biologics available and affordable to all!”

Univercells SAbrings together a group of Belgian and global biotech affiliates working together under a common mission (the “Group”). Each division of affiliates operates a different part of the healthcare value chain, through a distinct business model:

Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services and process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids.

Unizima delivers international project management of technology transfer, alongside operational support services (quality, supply chain, digital) and bioproduction training programs, as well as care centers and diagnostics surveillance centers.

Quantoom Biosciences is reinventing mRNA production by developing an mRNA production platform (NfinityTM) from sequence up to mass production.

RLM Consultingthanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background, RLM Consulting provides international regulatory affairs support at all stages of product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier for marketing authorization.

We deliver excellence and strive for innovation thanks to collaborative teams of passionate change-makers. We are driven by 5 core values in everything we do:Accountability, Continuous Improvement, Teach & Lead, Integrity, and Team spirit.

MISSION

Implement, maintain and continuously improve the quality management for the pharmaceutical research & development activities within Univercells.

RESPONSIBILITIES

As QA Specialist Research & Development , you will be responsible to:

Quality Management System for R&D

• Establish, implement, maintain, and continuously improve the specific quality management system for R&D activities by setting standards based on ISO 9001 requirements and ensuring continuous improvement of the activities.
• Provide training when necessary.

Operational oversight

• Oversights of the QA operations of the sites ( Andover, Evry, and others ….)
• Review related documentation such as development plans and reports, … .
• Participate in operational projects as QA expert.

Training:

Lead, coach and develop operational partners in the organization on the quality requirements for R&D, such as Data integrity, Good Documentation Practices and Good Scientific Practices.

Projects:

• Lead and contribute to corporate QA and QMS projects.
• Support affiliates R&D quality systems definitions and projects.
• Act as expert in R&D for projects and create if relevant adequate quality framework study.

Quality Culture, Mindset & Tools:

Disseminate and promote quality mindset throughout the organization and develop quality tools to support a R&D quality culture.

Inspections & Audits:

Participate in customer audits and ensure appropriate quality actions are being developed.

REQUIREMENTS / QUALIFICATIONS

• Technical writing skills
• Strongin communicationand team player
• Good influential skills
• Ability to work in fast-paced environments and to combine helicopter view and tactical actions.
• Fluent in French and English
• Demonstrate day-to-day application of Univercells’ values
• Experience in research and development of (bio)pharmaceutical processes (RNA and DNA processes, Cell culture, viral vector production).
• Experience in setting-up a fit for purpose quality system is considered as an asset.
• Experience in risk management is considered as an asset.
• Experience with inspections, audits and customer projects.

OUR OFFER

We offer a long-term contract (CDI), a competitive salary package including many interesting compensations and benefits (including the possibility to do regular homeworking), ad-hoc training to develop hard and soft skills, and the possibility of evolution in an international, dynamic, and fast-growing company.

Is this function of QA Specialist Research & Developmen t appealing to you? Do you want to work in a great and motivated team? Let’s meet! Apply!.

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