Jobs Research & development in Walloon Brabant:
3
jobs
Previous
of
Next
Manufacturing System Quality Partner
Contracting – Brabant Wallon
Manufacturing System Quality Partner
Job description
As a part of the Internal Bio & GT Manufacturing Systems Quality Team, you will:
- Work closely with Clinical Manufacturing Teams 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.
- More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation
- Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
- 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 the company development activities and products.
- Support Change Control and perform the QA evaluation
- Ensure KPI (including extracts) are adequately maintained and Shared.
- Ensure Issued Copy document are following the issued copy and reconciliation process
Profile
- Master’s degree in Sciences
- Fluency in French and English
- 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.
- QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems are an asset.
- 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
- Ability to work autonomously for the assigned activities with limited supervision
- Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
Offer
- Company car
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 or send me your CV, Show emailaddress
Previous
of
Next