QA CSV Specialist

R&D Partners; Ireland; On-site; EUR 50,000 - 70,000; Full time

Job summary

R&D Partners in Ireland seeks a QA Validation Specialist on a contract basis to validate LIMS, laboratory equipment, and computerized systems in a regulated pharmaceutical environment. This role supports data integrity and readiness for commercial operations as two products near launch.

This on-site position is based in Cashel and requires the right to work in Ireland. You will collaborate with Quality Control and IT to ensure compliant system setup and thorough documentation.

Qualifications

• Background in science, engineering, or a related technical field.
• Hands-on experience validating LIMS, lab equipment, and computerized systems.
• Familiarity with regulatory standards like GAMP 5, Annex 11, and 21 CFR Part 11.
• Strong communication and documentation skills.
• Ability to collaborate across teams.

Responsibilities

• Review and approve validation documents for lab systems and equipment.
• Oversee testing and qualification activities for computerized systems and lab instruments.
• Help create and maintain validation plans and related documentation.
• Ensure all validation activities meet regulatory standards and guidelines.
• Work with Quality Control and IT teams to ensure proper system setup and data security.
• Address and resolve issues related to lab system validation.
• Review and approve procedures, protocols, and technical documents.
• Participate in risk assessments and ensure data integrity for lab systems.
• Support audits and inspections as a SME for validation processes.

Skills

LIMS validation

Lab equipment validation

Computerized systems validation

Regulatory awareness

Cross-functional collaboration

Education

Science/Engineering degree

Tools

GAMP 5

Annex 11

21 CFR Part 11

Job description

Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

R&D Partners is seeking a QA Validation Specialist to join our team on a contract basis. In this role, you will focus on validating Laboratory Information Management Systems (LIMS), analytical lab equipment, and computerized systems in a regulated pharmaceutical environment. Your work will play a key role in ensuring data integrity, compliance, and readiness for commercial operations as the company prepares to launch two products by year-end. This is an on-site position based in Cashel.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Review and approve validation documents for lab systems and equipment.
• Oversee testing and qualification activities for computerized systems and lab instruments.
• Help create and maintain validation plans and related documentation.
• Ensure all validation activities meet regulatory standards and guidelines.
• Work with Quality Control and IT teams to ensure proper system setup and data security.
• Address and resolve issues related to lab system validation.
• Review and approve procedures, protocols, and technical documents.
• Participate in risk assessments and ensure data integrity for lab systems.
• Support audits and inspections as a subject matter expert (SME) for validation processes.

Key Skills and Requirements:

• Background in science, engineering, or a related technical field.
• Hands-on experience with validating LIMS, lab equipment, and computerized systems.
• Familiarity with regulatory standards like GAMP 5, Annex 11, and 21 CFR Part 11.
• Strong communication and documentation skills.
• Ability to collaborate effectively across teams.
• Experience supporting audits and inspections is a plus.