A start-up biopharmaceutical company based in Dublin, focused on developing and commercializing drugs, is currently recruiting for a Senior QA Manager. This company has a very strong pipeline of development stage drugs and has grown significantly over the last year. This position will be responsible for monitoring and supporting the quality performance of contract manufacturers, distributors and material suppliers to all applicable standards for GMP and GDP. If you are looking for a new challenge and to get in at ground level within a start-up environment, then this will be the perfect role for you.

What you will be doing in this role?

• Manage quality compliance within network of CMO's
• Reviewing and approving product complaints, deviations, change controls and leading product related investigations
• Conducts internal audits and assisting in regulatory agency inspections
• Support the development and implementation of the long-term Quality strategy and provide overall quality oversight to GDP practices
• Conduct QA review of draft GMP and GLP documents, when requested
• Responsible for CAPA and non-conformance management
• Conducts risk-based audits of service providers and internal systems - maintain audit files and tracking log.

Experience

• Bachelor and/or Master's degree in a scientific related discipline
• 4+ years of GMP/GDP experience
• Experience in a virtual organisation or working with CMO's is desirable

The Next Step for you...

Should this position be of interest to you please forward your CV to Camila Ignacio from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.

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