Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
Senior Quality Specialist
In this role your support the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of products. This departement interacts with functional units and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API,drug substance) and finished products with minimal risk to quality or product supply as responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.
Location: Geel
Scope of work:
As a Quality Specialist you act as the day-to-day liaison with internal and external customers for quality related activities.
- Ensure GMP compliance of products manufactured and/or tested at a contract facility.
- Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
- Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
- Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet Sanofi and GMP requirements.
- Contribute to the completion of milestones associated with specific projects.
Responsibilities:
Release product in accordance with approved specifications and procedures.
- Monitor contractor compliance via GxP documentation review and on-site visits/audits.
- Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.
- Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
- Interact with multi-functional internal and external project teams to ensure compliance.
- Respond to technical and quality issues and handle schedule and/or process-related conflicts.
- Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).
- Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
- Provide guidance to less experienced staff, as applicable.
Who are you?
- Bachelor or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include 3+ years in a Quality role
- Excellent communication and organizational skills.
- Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
You have to stay in Scotland for 3-4 weeks followed by +/- 6 weeks back in homeoffice and followed again by 3-4 weeks in Scotland. This would be for the whole assignment.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
