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Job Description
Seeking a detail-oriented QC/ARD Analyst to support laboratory setup, perform testing, manage consumables, and ensure compliance with cGMP standards in a dynamic environment.
We are a global leader in pharmaceutical manufacturing, committed to delivering top-quality products and services, ensuring adherence to the highest industry standards. Our Cashel site is at the forefront of innovation and excellence.
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 setup 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.