Senior QA
Il y a 5 heures
East Flanders, Flanders, Belgique
Pauwels Consulting
Temps plein
Gratuit avec email ou Google
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ppOur client, a leading biotechnology organization, is seeking an experienced professional to manage quality investigations and process improvements. This role is responsible for driving excellence in compliance and manufacturing within a highly regulated environment. /ph3Responsibilities /h3ulliReview and complete manufacturing and QC non-conformance and deviation investigations. /liliCollaborate with stakeholders to implement effective CAPA and ensure timely completion of corrective and preventive actions. /liliProvide recommendations for process improvements by working cross-functionally across the organization. /liliExecute improvements through the change management system in close collaboration with management. /liliReport and monitor quality metrics on investigations and corrective and preventive actions. /liliEnsure all tasks are performed in accordance with cGMP requirements and safety policies. /li /ulh3Requirements /h3ulliYou have 8+ years of relevant experience in a pharmaceutical or biotech quality environment. /liliYou bring expertise in CAPA lifecycle management, deviation management, and non-conformance investigations. /liliYou possess a strong background in GMP compliance monitoring and change control processes. /liliYou have experience using quality systems such as LIMS and investigation reporting tools. /liliYou're known for your advanced time management skills and ability to respond with urgency to cross-functional needs. /liliYou are fluent in English. /li /ulh3Nice to Haves /h3ulliExperience specific to CAR-T manufacturing or advanced therapies. /liliActive knowledge of Dutch. /li /ul /p