Quality Manager/Responsible Person
Our client, a speciality pharma company, are currently recruiting for a Quality Manager to join their team on a permanent basis. Our client have added a new medical device product to their portfolio and require a Quality Manager experienced working with medical devices and MDR as well as having GDP/RP/Deputy RP experience. This role is based in Dublin city centre with hybrid working.

Responsibilities:

• Buildingand maintaining a Quality Management System
• Continually maintaining audit-readiness of the Quality System
• Assisting in planning the internal audit schedules
• Handling complaints and processing post-marketing requirements for medical devices within the specified timelines (and ensure company complies with post-market surveillance and reporting obligations)
• Conducting corrective and preventative actions, updating the CAPA log and reporting the progress of the CAPA at scheduled quality and Annual Management review meetings
• Leading Supplier Management activities including supplier evaluation and maintaining an approved vendor listing
• Supporting on site audits of critical suppliers
• Handle and maintaindocumentation supporting MDR, ISO and GDP standards
• Managing warehouse and logistics including liaising with relevant company personnel ensuring receipt of regular inventory reports.
• Assisting in generating Quality Documentation, new SOPs etc
• Completing incoming inspection on Raw Materials
• Carrying out Risk Assessments and managing change controls
• Managing and monitoring training via ETQ. Managing and maintaining training files
• Completing final batch release approval including checks on batch documentation received from CMO
• Be point of contact for CMOs and distributors. Provide pro-active support for subcontractors strategically leading and directing to ensure key deliverables are achieved on time. Developing and maintaining a relationship to ensure a clear oversight of subcontracted responsibilities
• To act as the main point of contact with competent authorities and notified bodies
• Ensure Technical documentation and EU documentation of conformity are generated and up to date
• Maintaining up to date design and development documents

• BSc in Life Science/related Discipline
• Experience working with Quality Management Systems
• Experience working with Medical Devices and knowledge of MDR
• Experience working as an RP or Deputy RP