Bio DS Operations Quality Specialist
Brabant Wallon – Contracting
What are your responsibilities?
The Bio DS Operations Quality Officer will oversee Upstream/Downstream/Media and Buffer quality assurance activities specifically related to manufacturing operations within new commercial biologicals drug substance facility.
This role is crucial in ensuring compliance with internal standards. The position also involves driving continuous improvement in quality processes to uphold the highest standards of product quality and safety.
Additionally, this role involves connecting to appropriate stakeholders to ensure the alignment with production.
Quality Assurance:
- Review and approve deviations, corrective and preventative actions, and change controls.
- Review and approve Batch records.
- Ensure escalation of quality problems to the appropriate levels of management following the standards set by the QMS.
Regulatory Compliance:
- Participate in reviewing Annual Product Reviews.
Who are you?
- Bachelor or Master’s Degree in science (Biotechnology, Chemistry, Pharmacist,…)
- Minimum of 5 years’ experience in GMP Environment.
- Demonstrated strong experience in biologicals drug substance operations (business and/or quality).
- Demonstrate good communication skills with stakeholders.
- Fluent in French and English.
- Resistant to stress.
- Ability to create support for training
- Knowledge in other Biomanufacturing processes can be a advantage (validation, maintenance, metrology,…)
Our Offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.