Quality Operations Specialist

vor 4 Wochen

Bulle FR, Freiburg, Schweiz UCB Vollzeit

About the role

As a Quality Operations Specialist, your key responsibilities include ensuring compliance with national and international regulations, guidelines (GMP), and relevant UCB Quality Policies related to product delivery (Production, Supply Chain, Technical Services, Quality Operations, Business Acceleration, HSE&Q).

Key responsibilities

  • Provide quality support for product delivery from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, Change Control, Complaints, equipment/Utilities/Environment qualification, process/Cleaning validation, Product Quality Review, Continuous Process Verification.
  • Establish and maintain relationships with internal/external customers/stakeholders to provide efficient follow-up of product-related 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.

Required skills and experience

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.

Join UCB and contribute to making a difference in patients' lives

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