- 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,
- Equipment's/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.
- Master's degree in Life Sciences, and/or an 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 worker 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.
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Quality Operations QA Specialist - Bulle, Schweiz - UCB
Beschreibung
Make your mark for patients
About the role
As a Quality Operations QA Specialist, you are responsible for compliance activities and quality strategies about the operations related to products delivery (Production, Supply Chain,Technical Services, Quality Operations, Business Acceleration, HSE&Q) in compliance with national and/or international regulations, guidelines (GMP), and relevant UCB Quality Policies.
What you'll do
Interested? For this role we're looking for the following education,experience, and skills
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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
