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Electronic Batch Record System Specialist

vor 1 Woche

Neuenburg, Neuenburg, Schweiz gloor&lang AG Vollzeit

Are you looking for a challenging role that will utilize your technical expertise? Do you have a passion for ensuring excellence and compliance? We invite you to apply for the position of QA IT MES Specialist at gloor&lang AG.

About the Job:

This role offers the opportunity to work on cutting-edge projects that shape the future of healthcare. As a QA IT MES Specialist, you will be part of a globally renowned biopharmaceutical company, collaborating on innovative projects that make a real difference in people's lives.

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

Requirements:

  • Technical Background: Proven experience in Computerized System Validation (CSV) and a strong understanding of cGxPs and industry standards.
  • Language Skills: Fluency in English and French is essential.
  • Soft Skills: Exceptional communication and organizational skills to collaborate across diverse teams.
  • Flexibility: 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).