23n/ianc - Quality Compliance Officer - Antrim, United Kingdom - Randox Laboratories

Tom O´Connor

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Tom O´Connor

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Description

The Role:

  • Conducting internal audits to predetermined schedule.
  • Participation in external audits (Accreditation and Registered Bodies).
  • Conducting internal quality system audits.
  • Reviewing the CPA program and the assistance with the implementation of preventative actions.
  • Assisting with performance of supplier audits and assisting with Accreditation Body, Registration Body and Customer audits.
  • Support staff with design verification, validation, risk management and change control activities.
  • Interpretation of Quality and compliance with relevant National and International standards.
Please note that this job description is intended as a guideline
- new duties and responsibilities will be incorporated as a matter of custom and practice as the role evolves.


Essential:

  • Be educated to Degree level (Life science degree desirable) or relevant experience.
  • Previous experience of, or working in a, GMP, GLP, ISO 9001 or ISO 13485 related industry is essential.
  • Excellent communication skills (verbal and written) and ability to disseminate information in a concise manner throughout the Company.
  • Proficient in use of Microsoft word, Excel, PowerPoint etc.
  • Flexible approach and willingness to work outside hours if required.

Desirable:

  • Experience in a working knowledge of the MDSAP and the IVDD98/79EC
  • Experience in developing and conducting process validation studies.

About Randox:


Randox is a world leader in in-vitro diagnostics supplying a range of innovative laboratory instruments and tests to a wide range of customers across the globe.

High value is placed in research and development to continuously improve existing and develop innovative new products. This has allowed us to continuously grow and expand globally.

Founded in 1982, Randox is a family-owned company that has created over 1000 jobs worldwide. We play a pioneering role in laboratory medicine.

Working for Randox you not only have the opportunity to work with our cutting-edge new technologies, but you will also contribute to improving health care overall.

Randox Laboratories Limited is an Equal Opportunities Employer

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