Quality Projects Associate
il y a 2 semaines
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 procedures Coordinating regulatory submissions Providing crucial support for Quality Management Systems, including validation, Quality Risk Management (QRM), and change management Conducting 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 actions Supporting the creation and maintenance of Master Batch Records Actively contributing to continuous improvement initiatives Qualifications: 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 Biotechnology Know-how of project management within the pharmaceutical or related industries, with a strong focus on GMP-regulated and aseptic environments Strong analytical and problem-solving abilities, excellent organizational skills, and a meticulous, accurate, and quality-conscious work approach Strong communication, interpersonal, and technical writing skills to effectively collaborate with cross-functional teams and external stakeholders A perfect command of Dutch and good knowledge of English (written and oral) are required
-
Quality Projects Associate
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe 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...
-
Quality Projects Associate
il y a 1 jour
Puurs, Belgique Arcadis Temps pleinThe 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...
-
Quality Projects Associate
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe 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...
-
Project Quality Engineer
il y a 3 jours
2870 Puurs, Belgique Arcadis Temps pleinAs a Quality support project engineer within the ICS department, you will execute different support tasks which results a validated state of computer systems. These tasks are: Operational support by giving advise based on knowledge and experience of procedures so solutions for software and infrastructural problems can be implemented correctly. Responsible...
-
Project Quality Engineer
il y a 5 jours
Puurs, Belgique Arcadis Temps pleinAs a Quality support project engineer within the ICS department, you will execute different support tasks which results a validated state of computer systems. These tasks are:Operational support by giving advise based on knowledge and experience of procedures so solutions for software and infrastructural problems can be implemented correctly.Responsible for...
-
Project Quality Engineer
il y a 3 jours
Puurs, Belgique Arcadis Temps pleinAs a Quality support project engineer within the ICS department, you will execute different support tasks which results a validated state of computer systems. These tasks are:Operational support by giving advise based on knowledge and experience of procedures so solutions for software and infrastructural problems can be implemented correctly.Responsible for...
-
Project Quality Engineer
il y a 3 jours
Puurs, Belgique Arcadis Temps pleinAs a Quality support project engineer within the ICS department, you will execute different support tasks which results a validated state of computer systems. These tasks are: Operational support by giving advise based on knowledge and experience of procedures so solutions for software and infrastructural problems can be implemented correctly. Responsible...
-
Project Engineer Launch Excellence
il y a 2 semaines
2870 Puurs, Belgique Arcadis Temps pleinThis role entails being responsible for managing validation aspects associated with the introduction of new products into the site. The scope covers a broad range of activities required to ensure successful implementation and regulatory compliance throughout the product lifecycle. Key service activities include: Validating and documenting support for...
-
Project Engineer Lab Operations
il y a 2 semaines
2870 Puurs, Belgique Arcadis Temps pleinDit project situeert zich binnen de lab operations tech transfer (analytical) groep die verantwoordelijk zijn voor introductie van nieuwe analytiek tav introductie nieuwe geneesmiddelen/vaccines in de Puurs productieplant, in samenwerking met analytical R&D. De consulent is verantwoordelijk voor transfer/validatie en implementatie van analytische...
-
Lab Operations Project Engineer
il y a 2 semaines
2870 Puurs, Belgique Arcadis Temps pleinThe Lab Operations Project Engineer entails being responsible for the compliance assessment of method validation and compendial compliance dossiers. It involves the careful implementation of new test methods and procedures in Quality Control Operations, including coordinating and planning project activities. Your tasks: Writing and reviewing protocols,...
