QA Specialist

Summary:
A QA Specialist is required for a biopharmaceutical company in Dunboyne. This incumbent will be part of our client’s Quality Operations and Quality Systems team.

Responsibilities:

• The QA Specialist will work to identify and resolve issues in order to allow the site to deliver on a culture that supports Quality, EHS, Learning and Continuous improvement.
• This role will provide Quality Assurance (QA) oversight to qualification/validation, technical transfers, regulatory approvals and commercial operations.
• The QA Specialist will be responsible for oversight of Quality Systems across the site including supporting the Operations, Engineering, MS&T, QC and Plan and Procure teams, ensuring compliance with cGMP and corporate regulations.
• The QA Specialist will be responsible for supporting the Operations, Engineering, MS&T, QC and Plan and Procure teams, ensuring compliance with cGMP and corporate regulations.
• Support the development and coaching of key members of the Quality Assurance Operations and Quality Systems teams to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Liaises with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
• Ensures clear communication on issues and timely escalation as applicable.
• Drives opportunities for continuous improvement.

Qualifications & Experience:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• At least 9 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both) or equivalent.
• Organisation Skills, ability to manage multiple priorities and know when to escalate issues for resolution.
• Proven record of accomplishments in a regulated industry.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Demonstrated understanding of continuous quality / process improvement tools.