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Details

Quality Manager Combination Products


Reference:AFKX-174525 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager, QA RA Engineer, QA Supervisor

Quality Manager Combination Products
Our client, a global pharmaceutical organisation are currently recruiting for a Quality Manager to join their team on a permanent basis. The ideal candidate will have experience working with Combination Products.

Responsibilities
• Quality lead for Design reviews of Combination Products and Devices in conjunction with Device Development Team, Regulatory Affairs, R&D and Market Research Teams.
• Quality lead for risk benefit analysis for combination products/device programs
• Manage Quality Combination Products SOPs
• Ownership and preparation of Design Verification and Design Validation protocols/reports and risk and usability reports in support of Design History Files
• Support and facilitate post-approval activities such as Device Design changes
• Relationship management and regular communication with key medical device suppliers to facilitate development projects and supplier compliance with applicable device requirements
• Clinic trail involvement, such as formula studies, blinding studies and pK studies
• Drive Human factor studies that support regulatory submissions
• Responsibility for Quality aspects of device engineering and change control through the lifecycle of the Combination Products/Device project
• Oversight of device elements of complaints
• Participate in joint quality & technical assessments of suppliers and device partners
• Problem solve and trouble shoot as required
• Quality oversight for device manufacturing for pivotal manufacturing campaigns

Requirements
• 5+ years in a Quality role within a Combination Products or Medical Device field
• Degree in Science or Engineering or related pharmaceutical discipline
• Experience with Combination (Drug Delivery) Products
• Experience in medical device industry required a distinct advantage
• Experience in Respiratory and Injectable drug-delivery devices preferable
• Experience of clinical trials or late stage development manufacture to cGMP, process
• development and scale-up of pharmaceutical products is an advantage.
• Strong familiarity with ISO 13485, Quality Systems for Medical Devices & FDA QSR 21 CFR 820 required
• Working knowledge of Design Control/Design History File requirements
• Strong background in the application of ISO 14971:2012, Risk Management for Medical Devices, is essential
• Experience in the application of ISO 62366, Usability Engineering for Medical Devices
• Understanding of cGMP regulations/guidance in relation to all aspects of clinical
• manufacturing and a solid grasp of relevant engineering aspects of role
• Willingness to travel, 20-30%

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252