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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
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