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

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Quality Specialist

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

Job Summary:

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

Requirements:

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. 

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 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 tdunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

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