QA/Regulatory Compliance Officer/Auditor
T: +44 (0) 28 9442 2413
The successful applicant will be responsible for ensuring compliance with National and International Quality Regulations and Harmonised Standards by assisting with the development, maintenance and administration of the Randox Quality Management System and providing QA / Regulatory support to all Departments within the Company.
The role will involve:
• Conducting internal audits to pre-determined schedule
• Participation in external audits (Accreditation and Registered Bodies)
• Conducting internal quality system audits
• Reviewing the CAPA 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.
This is an excellent career opportunity; full training will be provided.
• Educated to Degree level (Life science degree desirable)
• 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.
• Experience in and a working knowledge of the MDSAP and the IVDD98/79EC
• Experience in developing and conducting process validation studies
Randox Laboratories are passionate about improving global health and saving lives through the development of innovative and pioneering products. Through our commitment and the skill of our people we have grown to be a world leader in diagnostics for clinical healthcare, toxicology, food security and providing quality solutions to over 145 countries. In order to serve our growing international markets we require high calibre applicants with scientific, engineering, software and broader business skills – including sales, marketing, logistics, finance and many more.
Central to the Randox ethos is our drive to improve healthcare worldwide and every one of our staff plays a vital role in this aim.
Randox Laboratories Limited is an Equal Opportunities Employer