Overview:
The Quality Specialist provides oversight and support for Quality Systems, ensuring compliance with regulatory standards and promoting continuous improvement within a collaborative production environment. This role requires expertise in Quality Management Systems, operational quality, and regulatory compliance to maintain the highest product and safety standards.
Key Responsibilities:
Provide quality systems and operational quality expertise, including quality notifications, investigations, change management, and sterility assurance.
Ensure compliance with regulatory requirements and maintain knowledge of regulatory updates.
Oversee and approve Commissioning and Qualification activities (IQ/OQ/PQ).
Identify solutions to complex quality issues and drive continuous improvement initiatives.
Act as a resource for less experienced colleagues and provide coaching.
Support site inspections by regulatory bodies and follow up on related actions.
Manage deviations and change controls, and contribute to project teams as required.
Participate in GMP Walkthroughs and ensure high-quality product supply through effective Quality Management Systems.
Requirements:
Degree or equivalent qualification in Science or Quality.
Minimum of 5 years experience in pharmaceutical or similar industries, including Quality roles.
In-depth knowledge of GMP, regulatory requirements, and Quality Assurance principles.
Demonstrated ability to work independently and lead small projects.
Strong problem-solving, coaching, and decision-making skills.
Proficient in MS Office applications (Excel, Word, PowerPoint).
Shift Pattern:
Week 1: Monday, Tuesday, Friday, Saturday, Sunday (11-hour shifts).
Week 2: Wednesday, and Thursday (11.5-hour shifts).
For a confidential discussion and more information on the role, please contact Kevin Griffin.
kevin.griffin@collinsmcnicholas.ie
(021) 2427108