Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
 Google Chrome |
 Internet Explorer |
 Mozilla Firefox |
 Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Print this job
Send Job Spec
Share on LinkedIn
Share on Facebook
Share on Twitter
Germany
Carlow
Galway
Athlone
North Leinster
Dublin
Clare
Carlow
Dublin
Leitrim
Dublin City Centre
Limerick
Denmark
Galway
Galway
Carlow
Dublin
Canada
Republic of Ireland
Galway
Galway
Kildare
Westmeath
Dublin
Carlow
Clare
Galway
Tipperary
Dublin
Dublin
Tipperary
Leitrim
Dublin
Dublin
Clare
Dublin
Limerick
Limerick
Carlow
Carlow
Westmeath
Dublin
France
Galway
Carlow
Tipperary
Galway
Tipperary
Dublin
Westmeath
Wexford
Dublin
Dublin
Limerick
Galway
Dublin
Westmeath
Dublin South
Dublin
Clare
Carlow
Carlow
Galway
Galway
Galway
Dublin
Limerick
Connaught
Athlone
Republic of Ireland
Denmark
Dublin
Clare
Galway
Galway
Dublin
Dublin
Galway
Limerick
Galway
Carlow
Dublin
Dublin
Athlone
Galway
Limerick
Dublin
Carlow
Galway
Carlow
Limerick
Connaught
Carlow
Galway
Limerick
Dublin
Galway
Dublin
Tipperary
Galway
Cork
Republic of Ireland
Limerick
Wexford
Carlow
Galway
Republic of Ireland
Carlow
Dublin
Limerick
Dublin South
Galway
Dublin
Dublin
Dublin
Dublin
Tipperary
Galway
Cork
Republic of Ireland
Galway
Clare
Wexford
Tipperary
Louth
Carlow
Republic of Ireland
Athlone
Dublin South
Dublin
Dublin
Athlone
Athlone
Galway
Carlow
Galway
Galway
Limerick
Dublin
Leitrim
Greece
North Leinster
Limerick
Athlone
Cork
Galway
Dublin South
Dublin
Tipperary
Dublin
Dublin
Leitrim
Dublin
Galway
Clare
Westmeath
Galway
Clare
Galway
Dublin
Longford
Republic of Ireland
Clare
Tipperary
Carlow
Westmeath
Clare
Galway
Republic of Ireland
Carlow
Carlow
Athlone
Cork
Leitrim
Dublin
Dublin
Tipperary
Dublin
Dublin
Dublin
Republic of Ireland
Wexford
Athlone
Dublin
Galway
Roscommon
Dublin City Centre
North Leinster
Westmeath
Dublin
Greece
Galway
Dublin
Carlow
Republic of Ireland
Galway
Carlow
Connaught
Dublin
Galway
Athlone
Dublin
Galway
Galway
Limerick
Carlow
Carlow
Limerick
Carlow
Athlone
Canada
Republic of Ireland
Athlone
Dublin
Westmeath
Cork
Connaught
Dublin
Galway
Carlow
Waterford
Athlone
Carlow
Dublin
Tipperary
Galway
Galway
Tipperary
Republic of Ireland
Cavan
Republic of Ireland
Louth
Carlow
Dublin
Dublin
Carlow
Cork
Leitrim
Galway
Roscommon
Galway
Carlow
Galway
Dublin
Republic of Ireland
Tipperary
Tipperary
Cork
Quality Manager / PRRC
| Reference: | SCA014193 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
Quality Manager / PRRC
Our client, a speciality Pharma company are currently recruiting for a Quality Manager and PRRC to join
their team on a permanent basis. The role will primarily cover the management of quality systems for
Medical Devices, as well as GDP Compliance for the Medicinal product. The role is based in Dublin City
Centre with hybrid working. Occasional travel outside of Dublin is required.
Responsibilities:
Quality Management System
• Build and maintain the Quality Management System (QMS)
• Create new SOPs and other quality documents
• Carry out risk assessments and manage change controls
• Manage the internal and external audit program and conduct and co-ordinate audits as required,
including GDP Self inspections
• Organise, manage and monitor training via ETQ and maintaining training files
• Maintain the quality management system comprised of ETQ (document management system)
documentation associated with company procedures ensuring audit-readiness at all times
• Handle complaints and processing post-marketing requirements for medical devices within the
specified timelines - In support of the PRRC PMS activities
• Conduct corrective and preventative actions, oversee the CAPA log and report the
progress of the CAPA at scheduled quality and annual management review meetings
• Manage warehouse including liaising with relevant company personnel ensuring receipt of
regular inventory reports, addressing any storage excursion
• Act as the main point of contact with competent authorities and notified bodies
• Oversee the handling and maintain documentation supporting MDR, GDP, MDSAP and ISO standards
• Report to management on the effectiveness of the quality management system and any need for
improvement
• Prepare and arrange the annual management review meetings
• Establish and review ongoing KPIs and objectives for the Quality Department
• Ensure the promotion of awareness of applicable regulatory requirements and quality
management system requirements throughout the organisation
• Quality Agreement Management
• Progress the application for MDD to MDR transition for Class IIa Medical Device
Legal Manufacturer Activities - Medical Device
• Complete inspection of incoming raw materials
• Maintain up to date design and development document
• Complete final batch release approval including checks on batch documentation received from CMO
• Ensure the Technical Files are maintained and updated as required
Supplier Management
• Lead supplier management activities including supplier evaluation and maintain an approved
vendor listing
• Act as point of contact within the Company for subcontracted activities carried out on behalf of the
company, such as contracted manufacturing organisations (CMOs) and distributors
• Provide pro-active support for subcontractors strategically leading and directing to ensure key deliverables
• are achieved on time
• Develop and maintain a relationship with CMO’s to ensure a clear oversight of responsibilities assigned to subcontractors
PRRC - Carry out the require duties as per Article 15 of EU 2017/745, for various Medical Devices
(Class I and Class IIa) including ensuring that:
• The conformity of the devices is appropriately checked, in accordance with the quality management
system under which the devices are manufactured, before a device is released
• The technical documentation and the EU declaration of conformity are drawn up and kept up to date
• The Post Market Surveillance obligations are complied with in accordance with article 10(10)
• The reporting obligations referred to in Article 87 to 91 are fulfilled
Requirements:
• Meet the regulatory requirements of a PRRC
• BSc in Life Science / related discipline
• Experience working with Medical Devices and knowledge of MDR
• Knowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, GDP 2013/C343/01
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
