We are seeking Quality System specialists to join our growing team at a leading Pharmaceutical manufacturer in Cork.
Job Description
This is a 11-month contract, on-site shift role. You will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting company priorities of: Compliance, Supply, Strategy and Profit Plan.
Key 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
Requirements:
* 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, Power Point) 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.