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Quality Projects Associate
il y a 5 jours
The Quality Project Associate focuses on quality oversight and project support where you will primarily deliver essential quality oversight and comprehensive project support for pharmaceutical processes and products within Belgian sites, specifically the aseptic manufacturing plant. You act as an independent quality authority for product-related qualifications and validations, ensuring regulatory CMC compliance of plant processes with regulatory filings, and contributing to compliant and right first-time product launches. Key responsibilities include:Performing quality reviews of validation documentation, change records, and proceduresCoordinating regulatory submissionsProviding crucial support for Quality Management Systems, including validation, Quality Risk Management (QRM), and change managementConducting end-to-end validations of new products (covering formulation, filling, and packaging), which involves preparing validation documents, monitoring production batches, analyzing results, and performing root cause investigations for deviations with proposed corrective and preventive actionsSupporting the creation and maintenance of Master Batch RecordsActively contributing to continuous improvement initiativesQualifications:Master's degree in a relevant scientific or engineering discipline, such as Industrial Engineering, Civil Engineering, Bio-engineering, or (Industrial) Pharmacy, or equivalent experience in fields like Biochemistry or BiotechnologyKnow-how of project management within the pharmaceutical or related industries, with a strong focus on GMP-regulated and aseptic environmentsStrong analytical and problem-solving abilities, excellent organizational skills, and a meticulous, accurate, and quality-conscious work approachStrong communication, interpersonal, and technical writing skills to effectively collaborate with cross-functional teams and external stakeholdersA perfect command of Dutch and good knowledge of English (written and oral) are required
