Compliance Specialist required for a leading medical device company based in Limerick. The companies FDA regulated Limerick facility has grown consistently over the last 20 years to become one of the most important sites in its global operations. This facility specialises in the production of disposable contact lenses in a state of the art operation which includes injection moulding, robotics, vision systems and sterilisation systems in a Class 100,000 cleanroom environment. The facility has over 50 fully automated manufacturing lines and the product is untouched by a human hand from start to finish of the process.
Performs planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures.
o Provides supplier or EM compliance expertise to the organization as required.
o Assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements.
o Performs audits of suppliers or EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
o Ensures audit reports are issued within the prescribed time frame.
EDUCATION AND EXPERIENCE:
o BS in a related science or engineering field of study;
o 7 or more years of related experience and/or training
o Proven ability to conduct and manage audits required.
o Computer Systems Validation experience preferred.
o The position will require approximately 60% travel both domestically and internationally.
If you are looking for an opportunity to work in a leading edge medical device facility with a focus on process innovation, automation and continuous improvement with steady personal growth and development opportunities then call us to find out more.
If this role is of interest, please call Regina at LSC on 021 4777 329 or apply directly through this advert