Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds

Job Details

Quality Specialist

Company: Thornshaw Recruitment
Reference: TD9704
Closing Date: 23 Mar 18
Type: Permanent
Salary (£): Negotiable

Job Summary:

My client, a leading healthcare company based in Dublin have a requirement for a Quality Specialist. 


My client, a leading healthcare company based in Dublin have a requirement for a Quality Specialist. This is a fixed term contract.

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 their 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. 

• 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 3rd level 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.

If you are interested in applying for this role please call Tina on +353 1 2784671 or email 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.

Apply for this job: Quality Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.