Quality Operations QA Specialist

vor 3 Wochen

Bulle, Schweiz UCB Vollzeit

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

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.

Interested? For this role we’re looking for the following education,experience, and skills

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.

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 

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