QA CSV Specialist

R Dpartners; Munster; On-site; EUR 45,000 - 65,000; Full time

Job summary

R&D Partners is seeking a QA Validation Specialist to join our Cashel team on a contract basis. You will validate LIMS, lab equipment and computerized systems in a regulated pharmaceutical environment to ensure data integrity and readiness for commercial operations as we prepare two products for launch.

The role requires hands-on validation, strong documentation, and collaboration with Quality Control and IT to meet regulatory standards such as GAMP 5, Annex 11 and 21 CFR Part 11.

Qualifications

• Background in science, engineering, or a related technical field.
• Hands-on validation of LIMS, lab equipment, and computerized systems.
• Experience with regulatory standards such as 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.

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

Regulatory compliance

Documentation

Cross-functional collaboration

Audit support

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.

For more information, please contact Billy O’Brien.

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