QA Officer Injectable Manufacturing

UCB

  • Eigenbrakel, Waals Brabant
  • Vast
  • Voltijds
  • 2 maanden geleden
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 management
  • Technology Transfer
  • Process validation
  • Equipment qualification
  • Cleaning validation
  • Stability studies
  • Filing submission preparation and follow up of RA commitments
  • Authoring and follow up of Product Quality Review/Continuous Process Verification
Participation to continuous improvement
  • Review/approval of Change control, Failure investigation, Deviations, CAPA plans
  • Participation to shopfloor oversight: shopfloor/ tier meeting presence, housekeeping tours, Quality oversight (witnessing/assessing the aseptic techniques)
  • Review and authorization of relevant SOP
  • Provide support in the preparation and execution of internal / external audits.
  • Assist Manager to achieve team objectives
  • Act as back up for other team QA Officers according to Manager instructions
Interested? For this position you’ll need the following education, experience and skills
  • Bachelor’s/master’s degree or an education in a relevant scientific discipline
  • Extensive experience in the pharmaceutical sector within QA, with experience in injectables being a major advantage
  • Fluent English and French communication (oral and written)
  • Fact-based decision-making process, accountability and delivering attitude
  • Excellent interpersonal relationship skills
  • Well-developed sense of discretion and ethics
  • Excellent team player attitude
  • Stress resistant, able to make quality/compliance decisions in a business environment
Are 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!About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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