Quality Operations QA Specialist

Faites la différence pour les patients

We are looking for a Quality Operations QA Specialistto join us in our Quality Operations team, based in our biotechnological manufacturing site in Bulle, Switzerland.

About the role

As a Quality Operations QA Specialist, you will be responsible for compliance activities and quality strategies with regards to the operations related to products delivery, and responsible to proactively support operations (on the floor) in the biotech production area.

What you’ll do

• Provide quality support related to products delivery from start to finish for the product 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.
• Participate actively for inspection/audits (before/during/after).
• Lead and/or participate to internal audits according to annual planning.
• Contribute to the redaction and/or approbation to 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.
• Ensure to identify back-up during absences and take back-up responsibilities for other QA Specialist members as needed.
• Identify gaps, suggest and/or lead improvement initiatives.
• Be responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing activities in the biotech production.

Interested? For this role we’re looking for the followingeducation, experience,andskills

• Qualified to master’s degree level in life science (Biology or Chemistry), or Pharmacist.
• Minimum 5 years professional experience in manufacturing, laboratory, quality assurance/control, regulatory affairs.
• Independent worker under tight and shifting priorities.
• Ability to coordinate multifaceted projects and to meet critical deadlines.
• Ability to work closely with operational teams in manufacturing area.
• Excellent meeting preparation and presentation skills.
• 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 medicinal product manufacturing.
• Demonstrated ability to write up scientific/technical documents.
• Ambassador for quality culture implementation at shop floors level.
• Excellent oral and written communications skills in French and in English.

Êtes-vous prêt à « aller au-delà » pour créer de la valeur et faire la différence pour les patients? Si cela vous parle, alors nous aimerions vous connaitre!

À propos de nous
UCB est une société biopharmaceutique mondiale, spécialisée dans la neurologie et l’immunologie. Nous sommes environ 8 500 personnes aux quatre coins du monde, inspirées par les patients et motivées par la science.

Pourquoi travailler pour nous ?

Chez UCB, nous ne nous limitons pas à réaliser des tâches, nous créons de la valeur. Nous ne craignons pas d’aller de l’avant, de collaborer et d’innover pour faire la différence auprès des patients. Nous avons une culture de bienveillance et solidarité où chacun se sent inclus, respecté et a des chances équitables de faire de son mieux. Nous « allons au-delà » pour créer de la valeur pour nos patients, et toujours dans une optique humaine, que ce soit pour nos patients, nos employés ou notre planète. En travaillant pour nous, vous découvrirez un monde où vous pourrez grandir et aurez la liberté de tracer votre propre chemin de carrière et accomplir votre plein potentiel.

En savoir plus sur la durabilité chez UCB et comment elle est intégrée dans notre approche commerciale.

UCB et ses filiales encouragent la diversité et l’inclusion au travail; Nous sommes un employeur équitable. Nous ne discriminons pas sur la base de la race/la couleur/la religion/le sexe/l’origine nationale/l’ancien combattant/le handicap/l’âge/l’orientation sexuelle/l’identité de genre.