Quality Assurance Expert for Electronic Batch Record Systems

Vor 4 Tagen


YverdonlesBains, Waadt, Schweiz gloor&lang AG Vollzeit
Join a Global Leader in Biopharmaceutical Innovation

We are seeking a skilled QA IT MES Specialist to join our team at gloor&lang AG.

  • Job Overview:
  • Ensure excellence and compliance during the implementation of an electronic batch record system.
  • Work alongside cross-functional teams to uphold the highest standards of quality and compliance.
Key Responsibilities:
  1. Represent Quality in site and global project teams, providing oversight and expertise on Computerized System Validation (CSV) and validation activities.
  2. Ensure all quality aspects of the project comply with Global Policies, SOPs, and GMP regulations.
  3. Review and approve key documentation, including risk assessments, validation protocols, and configuration specifications.
  4. Collaborate with project teams to address quality issues, organize QA activities, and promote compliance with data integrity standards.
  5. Act as a key QA liaison, ensuring seamless communication among stakeholders and supporting an agile validation approach.
Requirements:
  • Proven experience in Computerized System Validation (CSV) and a strong understanding of cGxPs and industry standards.
  • Fluency in English and French is essential.
  • Exceptional communication and organizational skills to collaborate across diverse teams.
  • A proactive mindset with the flexibility and dedication to meet project timelines.
  • Residency or work permit in Switzerland is mandatory (cross-border workers welcome).
What We Offer:
  • Be part of a globally renowned biopharmaceutical company.
  • Collaborate on cutting-edge projects that shape the future of healthcare.
  • Work in a state-of-the-art facility overlooking the beautiful Lake of Neuchâtel.


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