Our client is committed to identifying, developing and commercialising healthcare products internationally across a spectrum of therapeutic areas - including pharmaceutical, medical device and nutritional products. Due to continues company growth and expansion, they are seeking an experienced Quality Systems Specialist to join the team at their virtual operation in North Dublin.
Duties and responsibilities of the Quality Systems Specialist will include but are not limited to:
- Ensuring that the company continues to operate in accordance with European GMP/GDP regulations for drug products, food products, the Medical Device Directive/Regulations and ISO regulations for medical devices.
- Provide Administrative support to electronic eQMS system and training to new users as required.
- Maintaining and coordinating systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval.
- Logging product complaints follow up with suppliers on investigations in conjunction with the Manufacturing Specialist and close investigations within agreed timeframes.
- Lead and support projects from QA perspective including product launches into new territories and for new product introductions as required.
- Provide QA support on MDR Regulation Transition Project.
- Scope and implementation of new Artwork Management System.
- Coordinate internal audits, carry-out internal audits and ensure the review, monitoring, reporting of the inspections.
- Assist with preparation for Health/ Competent Authority and Notified Body inspections and prepare regulatory inspection responses.
You will have skills and experience in the following:
- 3rd level qualification in a science discipline.
- 5+ years of relevant experience in the pharmaceutical and/or medical device industries.
- User experience of electronic Quality Management Systems (system administrator would be an advantage).
- Strong background in the application of GMP/GDP and ISO 13485 standards.
- Previous experience in regulatory inspections, supplier audits and customer audits.
- High level of proficiency in Microsoft Word and Excel.
- Strong organisational skills, ability to prioritise work and systematic approach to tasks.
- Enjoy and thrive in a fast-paced environment.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.