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Senior Quality Assurance Specialist

vor 2 Wochen

Bulle FR, Freiburg, Schweiz Randstad Vollzeit

Job Description

The Bio DS Local Quality Specialist plays a pivotal role in promoting high-quality standards and ensuring their seamless integration into operations. This position involves overseeing product documentation to guarantee full product knowledge and implementing improvements in response to business needs, operational excellence, quality, or regulatory requirements.

Main Responsibilities

  • Collaborate with local and global teams to promote high-quality standards, integrating them into operations, and oversee product documentation to ensure full product knowledge.
  • Implement improvements in response to business needs, operational excellence, quality, or regulatory requirements.
  • Lead the site Change Control Committee, ensuring smooth and coherent management of changes and regulatory impacts.
  • Support site manufacturing and supply activities, particularly product changes, in compliance with GxP and UCB quality standards.
  • Drive and develop the on-site quality culture, influencing teams to embed quality practices into daily activities.
  • Provide support and expertise in quality systems to help business partners fulfill their quality responsibilities.
  • Approve and authorize quality SOPs, Change Control, deviations, and related documents, while maintaining oversight of product-related documentation.
  • Contribute to the efficient follow-up of product-related change controls by managing relationships with internal and external stakeholders, including CMOs.
  • Review and approve validation protocols, CPV (Continuous Process Verification) reports, and Product Quality Reviews (PQRs).
  • Contribute to investigations when necessary, ensuring effective follow-up of deviations, incidents, investigations, and CAPAs (Corrective and Preventive Actions).
  • Actively contribute to simplifying and streamlining processes to remove obstacles and support continuous quality improvements.
  • Participate in quality strategies for projects within your area of responsibility, providing support and expertise as needed.
  • Approve protocols and reports for projects with regulatory impact.
  • Perform Batch record review and Release / Reject activities as needed; actively contribute to the achievement of Team's objectives.