Antwerp – Contracting Our partner is looking for a Quality Project Associate to join its team. This international company is well known for its pharmaceuticals. 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
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)
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.