An exciting opportunity has arisen for a permanent Senior Quality Ops Specialist within a leading global Biopharmaceutical organisation based in North Dublin. The focus of this role will be to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing

What you will be doing in the role:

• Support the GMP/GDP training program
• Support processing of Product Quality Complaints
• Support Change Control Management System and processing
• Run and provide quality metric data
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
• Participation in the internal and external audit program
• Authoring, review and approval of QA related procedures
• Development and maintenance of the Documentation Management System
• Documentation support for manufacturing
• Record Retention and archival systems
• Provide support to Tech Transfer projects

What you will need:

• Minimum BSc. in a Scientific related discipline
• 5+ years' experience working in Quality Assurance role in a GMP Life Science environment
• External Manufacturing or Quality Operations experience
• Understanding of Investigations and Change Control
• Approval of Quality documentation including validation protocols
• Internal/ external audits

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 1 960 9773.

Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement & Operations.

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