Quality Pharma Specialist
La Gruyère - Switzerland
Job Summary
Make your mark for patients
We are looking for a Quality Pharma Specialist who is eager to join our Quality team based in our manufacturing site in Bulle Switzerland.
About the role
As a Quality Pharma Specialist you are responsible for compliance activities and quality strategies relating to products delivery (Production Supply Chain Technical Services Quality Business Acceleration) in compliance with national and/or international regulations guidelines (GMP) and relevant UCB Quality Policies.
What youll do
- Provide quality support related to product delivery from start to finish for the product(s) in charge including management of activities and processes related to:
- Deviations OOS CAPAs Change Control Complaints
- Equipments/Utilities/Environment qualification
- Process/Cleaning validation Product Quality Review Continuous Process Verification
- Master data activation
- GxP documentation.
- Establish and maintain relationships with internal/external customers/stakeholders to provide efficient follow-up of product related to deviations change controls investigations incidents CAPA complaints etc.
- Enforce Compliance of stakeholders related to relevant product flow UCB standards and GxP.
- Ensure through procedures that equipment/process are qualified/validated according to current Guidelines.
- Lead and/or participate actively to internal audits/inspections according to annual planning.
- Contribute to the redaction and/or approbation of SOPs Methods Specifications Master Batch Record etc.
- Actively contribute to Product Quality Reviews (PQR) Continuous Process Verification (CPV); and to investigations as needed.
- Perform Batch record review and Release/Reject activities as needed and as delegated by the RP.
Interested For this role were looking for the following education experience and skills
- Masters degree in Life Sciences and/or equivalent working experience.
- A minimum of 3 to 5 years of experience in manufacturing laboratory quality assurance/control regulatory affairs.
- Ability to coordinate multifaceted projects and to meet critical deadlines.
- Independent and autonomous mindset working under tight and shifting priorities.
- Ability to work closely with operational teams in manufacturing and laboratory areas.
- Excellent negotiation and convincing skills.
- Well-developed sense of discretion.
- Demonstrated oral and written communication capabilities with varying culturally diverse groups and/or individuals and/or functions.
- Demonstrated understanding of the GxP environment and technical competence in core areas of pharmaceutical product manufacturing.
- Demonstrated ability to write up scientific/technical documents.
- Excellent oral and written communications skills in French and in English.
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 over 9.000 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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.
At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.
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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Required Experience:
IC
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more