QC Analyst

Job Title: QC Analyst

Location: Cashel, Co. Tipperary

About the Company:

A global leader in pharmaceutical manufacturing, our Cashel site is at the forefront of innovation and excellence. We are committed to delivering top-quality products and services, ensuring adherence to the highest industry standards.

Job Summary:

We are seeking a highly skilled and motivated QC/ARD Analyst to join our team in Cashel. The successful candidate will play a key role in supporting the laboratory setup, performing essential testing, managing consumables, and ensuring compliance with cGMP standards. This is an exciting opportunity for a detail-oriented professional to thrive in a dynamic environment.

Key Responsibilities:

• Support Laboratory Set-up activities.
• Prepare laboratory procedures, specifications, protocols, and reports as required.
• Perform laboratory testing and investigations in accordance with SOPs, cGMP, and applicable regulations.
• Conduct peer reviews of documentation as needed.
• Perform analytical method verification, validation, and technical transfer.
• Support site and laboratory EHS governance.
• Manage laboratory consumables, including ordering and tracking.
• Assist in equipment qualification activities, ordering, and tracking.
• Provide day-to-day support to laboratory colleagues.
• Collaborate with other departments as requested by the Laboratory Manager.
• Assist in preparation for regulatory audits/visits and maintain ongoing audit readiness.
• Contribute to the development of QC testing processes.
• Liaise with CROs and conduct audits where appropriate.
• Ensure all required training is completed to meet quality standards.
• Report any quality, process, or material issues to the Head of Department.
• Work closely with technicians, engineering, operations, and warehouse teams.
• Follow documented policies and procedures in line with the company’s Quality Management System.
• Complete all required documentation in compliance with Good Documentation Practice procedures.
• Maintain a clean and organized workspace to ensure product security.
• Perform analytical balance calibrations in line with relevant QC SOPs.
• Execute other activities as required by the Head of Department.

Requirements:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Science, or a related discipline.
• Experience in a cGMP-regulated laboratory, with a focus on QC and ARD processes.
• Strong understanding of laboratory procedures, method validation, and technical transfer.
• Proficient in documentation, reporting, and good documentation practices.
• Excellent communication and teamwork skills.
• Ability to manage multiple tasks and meet deadlines in a dynamic work environment.

Benefits:

• Base Salary.
• Annual bonus
• Flextime available.
• Laya Healthcare coverage for employee, partner, and dependents.
• Pension plan with 5% employer and employee contributions.
• Educational assistance program and support.

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