At Univercells Technologies, 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!! This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Nivelles (Belgium), reporting to the Head of Quality and Validation.
As Quality Assurance specialist single use systems (S.U.S), you will be the main QA stakeholders for projects teams involved in S.U.S development and qualification. You will also be part of overall Quality & Validation initiatives such as process definition & oversight, supplier qualification and audit readiness program.
- Act as QA stakeholder in S.U.S project team meetings, identify quality risks and escalate them if necessary
- With Validation Department, gather & summarize regulations pertaining to S.U.S to define the quality standard for S.U.S development and qualification
- Ensure quality by design is applied throughout the whole product development phases
- Ensure the company validation & quality principles are applied in the S.U.S development projects
- With Validation department, build and maintain knowledge management linked to S.U.S.
- Review & approve development and validation protocols, validation plans and design review
- Review validation guides
- Participate in supplier selection & qualification
- Act as accountable for one or more quality processes: process definition, implementation, oversight and continuous improvement (depending on process maturity).
- Be back-up of other quality peers when necessary
- MsC in Sciences, (Bio)Engineering, Pharmacy or similar
- At lest 8 years of experience in pharma/biotech environment
- Deep knowledge of GxP
- Pertinent experience in validation and single use systems
- Knowledge of Gene Therapy is an asset
- Good writing skills
- Strong analytical mind
- Ability to work in a fast paced environment
- Team spirit
- Fluent in English & French
We offer a long-term contract, a competitive salary package (health insurance, pension plan, meal vouchers…) 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 !