Operations Quality Partner
Contracting – Walloon Brabant
Your responsibilities?
- Work closely with Internal Bio Clin Manufacturing Team to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
- Ensure quality review of master and executed batch records for drug substance supporting clinical trial studies
- Release of materials used in production of drug substance for clinical trials
- Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review /approval Tech Transfer).
- Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
- Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products. – Support Change Control and perform the QA evaluation
- Provide quality support for qualification and validation activities related to Biotech Sciences activities
Your profile?
- QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is an asset.
- A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
- Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
- Understands practical applications of GMP, compliance principles and theories including risk management
- Good written/oral communication in English
- Ability to work autonomously for the assigned activities with limited supervision
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. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]
