Our client, a global biopharmaceutical leader, are seeking an experienced External QA Specialist to join the external quality group. The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

The Role

Duties and responsibilities of the External QA Specialist will include:

• Manage and own NC records for External Quality
• Manage and own CAPA records for External Quality
• Manage and own Change Control records internal to External Quality
• Manage and drive Quality records to closure independently
• Perform tactical batch disposition activities in support of lot release
• Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR)
• Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)

The Person

You will have skills and experience in the following:

• BSc in Science related discipline or similar
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.