Qualified Specialist D12 €35K 6-9 Month

GHL Recruitment

D12, Dublin South

QUALIFIED SPECIALIST - €35k -6-9 month contract position. Reporting to: Quality Manager. Core Responsibilities: - Support the Quality Manager in obtaining certification to I.S. EN ISO 13485: 2106 while maintaining compliance to Good Distribution Practice (GDP) for Medicinal Products and Medical Devices. Assist the Quality Manager in transferring from a paper based document management system to our corporate Integrated Management System. Document Management System: Defining Quality Procedures in conjunction with operating staff, while ensuring compliance with I.S. EN ISO 13485: 2106 and GDP. Restructuring the Document Management system in compliance with our Corporate Integrated Management System. Audits- Corrective and Preventive Actions: Conducting quality audits against the I.S. EN ISO 13485: 2106. Preparing audit reports, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken. Quality Risk Management. Assist Risk Owner’s and process owners in assessing risks and assigning counteractive measures. Maintaining Quality Risk Management files. Training: Ensure the Quality Management System is understood by providing training to personnel on updated documents, when required. Maintain Quality Training files. Incidents /Deviations. Record, investigate and report incidents and deviations to the Responsible Person. External Contractors. Liaise with external contractors in relation to all aspects QMS and regulatory compliance. Conducting Supplier Audits and assessments as required. Skills & Experience Requirements: Essential: This position requires a proven and solid understanding and working knowledge I.S. EN ISO 13485: 2016. Relevant 3rdlevel qualification is desirable along with previous experience of >2 years in a quality assurance role in the Medical Device /Pharmaceutical industry. Essential: A certified and experienced Quality Auditor capable of leading compliance audits. Knowledge of Quality Management Systems, and Good Distribution Practices. A hands-on individual with exceptional verbal and written communications skills who possesses a proactive and collaborative work style and the ability to work with multiple priorities and deadlines. Accuracy and excellent attention to detail are key attributes along with excellent organisational skills. A strong team player as well as the ability to work on ones own initiative. Proven interpersonal skills and the ability to communicate with people at all levels within an organisation. Must be highly proficient in Microsoft Office applications and Document Management systems. Essential Requirements: Fully eligible to work in Ireland. Proficiency in English language is essential both written and oral. For further information, please contact: Fiona Ralph at GHL 016610911. This job originally appeared on RecruitIreland.com.

2254 days ago