Senior QA Specialist

A well-established CDMO Multinational biopharmaceutical are experiencing further growth throughout their global operations. With a headcount of almost 2,500 people globally, they are looking to hire within their QA team here in Dublin due to new product development and continued expansion. The role is a Senior Quality Assurance Specialist and will be operating on a hybrid basis.

The Position

• The Senior QA specialist will conduct or serve as a leader of investigations and CAPA recommendations related to the organization's products.
• You will be responsible for Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination products for the business.

• The Senior QA specialist will perform Batch review, management of changes, complaints, deviations, validations, and product annual reviews to ensure completeness, accuracy, and compliance at all times.
• You will Co-ordinate with contract manufacturing quality and operations teams to independently resolve discrepancies while liaising with internal quality groups to ensure on-time disposition of finished product.
• You will support the stability program for combination products as required, facilitating communication and data acquisition between all the relevant stakeholders.
• Responsible for identifying defects and have the authority to report on product defects at any time.

The Person

• You will be degree qualified in a in Engineering or Science or technical discipline
• Experienced in Medical Device and Pharmaceutical industry sectors.
• Comprehensive knowledge of cGMP, Manufacturing and Quality Assurance experience.
• You will operate efficiently in a complex international organization making sound decisions regarding compliance-related issues with minimal supervision.

The Benefits

• Pension
• Private Healthcare
• Dental and eye care
• Bonus
• Hybrid working model

To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.