QA Officer Injectable Manufacturing

il y a 2 semaines

Brainel'Alleud, Belgique UCB Temps plein

Make your mark for patientsTo strengthen our Pharma & Injectable Pharma department we are looking for a talented profile to fill the position of: QA Officer Injectable Manufacturing– Braine l’Alleud, BelgiumAbout the roleYour duties will ensure that local technical operations related to the manufacturing of injectable pharmaceutical products comply with applicable national and international regulations and guidelines (GMP), as well as relevant UCB Quality Policies. Additionally, you will oversee that marketed injectable pharmaceutical products are manufactured and supplied in accordance with UCB Product Quality Standards. You will proactively help operations identify, develop, and implement quality and operational excellence improvements in response to business requirements, technical changes, and regulatory requirements.You will work withThis QA Officer for Injectable Manufacturing will work closely with several key groups at the UCB Braine site. Most importantly, they will collaborate with appropriate management and the Injectable Manufacturing department to ensure that all injectable pharmaceutical products are made according to strict quality and safety standards. This includes working with technical operations teams to make sure production follows national and international regulations (like GMP), and that the final products meet UCB’s internal quality standards. They will also support cross-functional teams by helping identify and implement improvements in quality and efficiency, especially when there are changes in business needs, technology, or regulations. Their role is central to maintaining a strong Quality Management System and ensuring smooth coordination between quality assurance and manufacturing teams.What you will doParticipation to product life cycle managementTechnology TransferProcess validation Equipment qualification Cleaning validation Stability studiesFiling submission preparation and follow up of RA commitmentsAuthoring and follow up of Product Quality Review/Continuous Process VerificationParticipation to continuous improvementReview/approval of Change control, Failure investigation, Deviations, CAPA plansParticipation to shopfloor oversight: shopfloor/ tier meeting presence, housekeeping tours, Quality oversight (witnessing/assessing the aseptic techniques) Review and authorization of relevant SOPProvide support in the preparation and execution of internal / external audits.Assist Manager to achieve team objectivesAct as back up for other team QA Officers according to Manager instructionsInterested? For this position you’ll need the following education, experience and skillsBachelor’s/master’s degree or an education in a relevant scientific disciplineExtensive experience in the pharmaceutical sector within QA, with experience in injectables being a major advantageFluent English and French communication (oral and written) Fact-based decision-making process, accountability and delivering attitudeExcellent interpersonal relationship skillsWell-developed sense of discretion and ethicsExcellent team player attitudeStress resistant, able to make quality/compliance decisions in a business environmentAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

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