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Technical Validation Specialist
vor 2 Wochen
As a gloor&lang AG team member, you will have the opportunity to work on cutting-edge projects that shape the future of healthcare. The role of a QA IT MES Specialist is a key position in ensuring excellence and compliance during the implementation of an electronic batch record system.
Job Responsibilities:- Represent Quality: Provide oversight and expertise on Computerized System Validation (CSV) and validation activities in site and global project teams.
- Ensure Compliance: Ensure all quality aspects of the project comply with Global Policies, SOPs, and GMP regulations.
- Review and Approve Documentation: Review and approve key documentation, including risk assessments, validation protocols, and configuration specifications.
- Collaborate with Project Teams: Collaborate with project teams to address quality issues, organize QA activities, and promote compliance with data integrity standards.
- Liaise with Stakeholders: Act as a key QA liaison, ensuring seamless communication among stakeholders and supporting an agile validation approach.
Requirements:
- Proven Experience: Proven experience in Computerized System Validation (CSV) and a strong understanding of cGxPs and industry standards.
- Languages: Fluency in English and French is essential.
- Communication Skills: Exceptional communication and organizational skills to collaborate across diverse teams.
- Mindset and Flexibility: A proactive mindset with the flexibility and dedication to meet project timelines.
- Residency or Work Permit: Residency or work permit in Switzerland is mandatory (cross-border workers welcome).
