Qcard Analyst Job In Munster

Job Description

Job Title: QC/ARD 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:

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

Requirements:

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

Benefits:

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