QA Engineer Alliance Products
Geel – Contracting
Our partner is looking for a QA Engineer Alliance Products to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Key Responsibilities:
- Ensure GMP compliance 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, and product investigations.
- Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet Sanofi and GMP requirements.
- Contribute to the completion of milestones associated with specific projects.
Core Responsibilities:
- Review batch abstracts to release products in accordance with approved specifications and procedures.
- Monitor contractor compliance via GxP documentation review and on-site visits/audits.
- 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 regulations related to the manufacture of medicinal products (biologics).
- Manage notification flows in quality systems between internal and external partners
- Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.
- Provide guidance to less experienced staff, as applicable.
Your profile?
- Bachelor’s or Master's degree and 3-5 years of experience in a cGxP or other regulated environment, whereof 3 years in a quality role. Experience in a regulatory affairs (RA) role is a plus
- Excellent communication and organizational skills.
- Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
- Being fluent in English is a requirement (writing & speaking), Dutch is a plus
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.
