Quality Systems Specialist

11 Month contract
On - site Cork
Shift role 5/2
AMC22465

I am looking for several Quality System specialists to join a growing team in a leading Pharmaceutical manufacturer in Cork.

If you have 5+ years experience in QA roles in Pharmaceutical manufacturing with an in depth knowledge of Quality System this could be the role for you!

In this role you will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan.

The role is a shift, full time onsite role providing quality oversight to Operational areas on site . This role is integrated in the production area.

The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.

Primary Responsibilities:

• Provide expertise in Quality Systems and Operational Quality (e.g., Quality Notifications, Investigations, Change Management, environmental monitoring, sterility assurance).
• Lead continuous improvement initiatives, resolve complex issues, and execute tasks.
• Act as a resource for colleagues, guiding on Quality Systems and compliance requirements.
• Ensure regulatory compliance and remain up to date with evolving standards.
• Oversee and approve commissioning/qualification activities (IQ/OQ/PQ).
• Identify solutions to non-standard requests, ensuring decisions align with policies and impact quality, projects, and systems.
• Support Corporate Quality in executing site-related Quality System actions.
• Contribute to inspections, GMP walkthroughs, deviation management, and change control approvals.
• Drive high product quality and compliance standards through the Quality Management System.
• Lead small projects, coach colleagues, and manage stakeholder relationships.
• Maintain safety standards and assist with other tasks as assigned by the QA Lead

• Degree or equivalent qualification in Science or Quality.
• 5+ years’ experience in the pharmaceutical/chemical manufacturing industry in Quality Assurance roles.
• In-depth knowledge of regulatory requirements and Quality Systems.
• Proven ability to work independently, lead projects, and coach teams.
• Advanced PC skills (Excel, Word, PowerPoint) and strong problem-solving abilities.
• Exceptional communication, decision-making, and stakeholder management skills.
• Energetic and proactive with a commitment to maintaining the highest standards of quality and compliance.