Quality Validation Auditor

2 weeks ago

Glasgow, United Kingdom Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

**Your Role**:
The Quality Validation Auditor reports to Quality Manager/Supervisor. The job holder will carry out the assigned tasks with competence and to undertake any other reasonable duties which are assigned by Quality Assurance Management. To conduct in -process and product quality audits across Operations areas to ensure compliance to the Quality Management System, GMP or GLP Regulatory Standards, relevant Standard Operating Procedure (SOP's), and customer specification. Constantly work within Operational departments to reduce the risk of quality findings.
- Review and approve validation documents against regulatory and internal requirements as to include, as applicable, requirements, risk assessments, protocols, testing, final/summary reports, trace matrix, etc.
- Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
- Review and approve minor, major and critical impact deviations / OOS records.
- Conduct trend analysis for deviations and review / approve applicable CAPA records.
- Provide support for client regulatory submissions, client audits and supplier audits.

**Who You Are:
- Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area.
- 2+ years' experience in Quality Assurance or related field within a GxP environment.
- Acts ethically and ensures quality of own work and that of others.
- Open-minded, flexibility and works with agility.
- Conduct laboratory audits as needed.
- Takes responsibility for ensuring that turnaround times are met.
- Works with cross-functional teams and builds networks within QA and Operations departments.
- Collaborates with various teams to identify and implement improvements.
- Strong communication and interpersonal skills.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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