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Regulatory Compliance Expert

vor 2 Monaten


Bulle FR, Freiburg, Schweiz UCB Vollzeit

About the Role

As a Quality Assurance Specialist at UCB, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. Your responsibilities will include:

  • Providing quality support for product delivery from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, Change Control, Complaints, and GxP documentation.
  • Establishing and maintaining relationships with internal and external stakeholders to provide efficient follow-up of product-related issues.
  • Enforcing compliance with relevant regulations, guidelines, and UCB standards.
  • Leading and participating in internal audits and inspections.
  • Contributing to the development and approval of SOPs, methods, specifications, and master batch records.
  • Performing batch record reviews and release/reject activities as needed.

Requirements

To be successful in this role, you will need:

  • A Master's degree in Life Sciences or an equivalent working experience.
  • A minimum of 3 to 5 years of experience in manufacturing, laboratory, quality assurance/control, or regulatory affairs.
  • 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.
  • Excellent oral and written communications skills in French and in English.

What We Offer

As a Quality Assurance Specialist at UCB, you will have the opportunity to work in a dynamic and challenging environment, contributing to the development and delivery of high-quality pharmaceutical products. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.