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Cytiva

Compliance Specialist

Job Posted 25 Days Ago Posted 25 Days Ago
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Cardiff, South Glamorgan, Wales
Mid level
Cardiff, South Glamorgan, Wales
Mid level
Assist in site QMS compliance with relevant medical device standards, coordinate audits, manage quality documents, and support training activities.
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Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Assists in site QMS compliance to relevant standards and regulations for medical devices – ISO13485, ISO9001, FDA 21 CFR 820. MDSAP, EU MDR

What you will do:

  • Site Quality Document Controller e-document systems (Veeva Vault & Magic) performing Document Control, Global & Site level document assessments
  • QMS Records Control
  • Data collation and reporting to site for QMS
  • Assist in coordination of Customer & Certification Audits and Regulatory Inspections
  • Learning Administrator for site (Cytiva Learning – Cornerstone) and support in training activities for Document Management Systems

Who your are:

  • Hold a Degree or Secondary School Education Certificates, preferably in Science, Business, or Engineering or h
  • Extensive strong working knowledge of quality assurance principles and practices, industry and international regulations and standards for medical devices
  • Knowledge of Quality Auditing advantageous
  • Excellent organisational skills along with strong attention to detail and time management

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Top Skills

Cornerstone
Cytiva Learning
Fda 21 Cfr 820
Iso13485
Iso9001
Magic
Veeva Vault

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