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Antwerp – Contracting
Our partner is looking for a Quality Project Associate to join its team. This international company is well known for its pharmaceuticals.
Our partner is looking for a Quality Project Associate to join its team. This international company is well known for its pharmaceuticals.
Quality Project Associate
Functieomschrijving
The Quality Project Associating services focus on quality oversight and project support, delivering essential quality oversight and comprehensive project support for pharmaceutical processes and products within the company Belgian sites, specifically the aseptic manufacturing plant. Provide technical, operational, compliance, and qualification support for GMP and non-GMP systems
- Provide quality oversight and comprehensive project support for pharmaceutical processes and products
- Act as an independent quality authority for product-related qualifications and validations
- Ensure regulatory CMC compliance of plant processes with regulatory filings
- Contribute to compliant and right first-time product launches
- Perform quality reviews of validation documentation, change records, and procedures
- Coordinate regulatory submissions
- Support Quality Management Systems, including validation, Quality Risk Management (QRM), and change management
- Conduct end-to-end validations of new products (formulation, filling, and packaging)
- Prepare validation documentation
- Monitor production batches
- Analyze validation results
- Perform root cause investigations for deviations and propose corrective and preventive actions
- Support the creation and maintenance of Master Batch Records
- Actively contribute to continuous improvement initiatives
Profiel
- Master’s degree in a relevant scientific or engineering discipline (Industrial Engineering, Civil Engineering, Bio-engineering, (Industrial) Pharmacy) or equivalent experience in Biochemistry or Biotechnology
- Know-how of project management within the pharmaceutical or related industries
- Strong experience in GMP-regulated and aseptic environments
- Strong analytical and problem-solving skills
- Excellent organizational skills
- Meticulous, accurate, and quality-conscious work approach
- Strong communication, interpersonal, and technical writing skills
- Ability to collaborate effectively with cross-functional teams and external stakeholders
- Perfect command of Dutch and good knowledge of English (written and oral)
Aanbod
- Bedrijfswagen
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.
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