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