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Quality Assurance Expert

vor 2 Wochen


Neuenburg, Neuenburg, Schweiz gloor&lang AG Vollzeit

We are seeking a highly skilled QA IT MES Specialist to join our team at gloor&lang AG. As a key member of our team, you will be responsible for ensuring excellence and compliance during the implementation of an electronic batch record system.

About the Role:

This is a unique opportunity to work on cutting-edge projects that shape the future of healthcare. You will be part of a globally renowned biopharmaceutical company, collaborating on innovative projects that make a real difference in people's lives.

Responsibilities:
  • CSV Expertise: Provide expertise on Computerized System Validation (CSV) and validation activities in site and global project teams.
  • Compliance Management: Ensure all quality aspects of the project comply with Global Policies, SOPs, and GMP regulations.
  • Documentation Review: Review and approve key documentation, including risk assessments, validation protocols, and configuration specifications.
  • Collaboration: Collaborate with project teams to address quality issues, organize QA activities, and promote compliance with data integrity standards.
  • Liaison Services: Act as a key QA liaison, ensuring seamless communication among stakeholders and supporting an agile validation approach.

What You'll Bring:

  • Technical Expertise: Proven experience in Computerized System Validation (CSV) and a strong understanding of cGxPs and industry standards.
  • Linguistic Skills: Fluency in English and French is essential.
  • Interpersonal Skills: Exceptional communication and organizational skills to collaborate across diverse teams.
  • Adaptability: A proactive mindset with the flexibility and dedication to meet project timelines.
  • Eligibility: Residency or work permit in Switzerland is mandatory (cross-border workers welcome).