Senior QA Validation Lead for GxP IQ/OQ/PQ

Cpl Group; Dublin; On-site; EUR 54,000 - 66,000; Full time

Job summary

Cpl Group is seeking a QA Validation Manager to lead qualification and validation activities for equipment, control systems and computer systems within the Life Sciences business in Ireland. The role requires a strong background in GxP, EU GMP/GDP, and successful delivery of QA projects.

Applicants should have a Bachelor’s degree in a related field and formal training in Validation or CSV. The position involves management responsibility and collaboration with suppliers, sites, and regulators.

Qualifications

• Bachelor’s degree or higher in Science, Engineering, Pharmacy, Quality or related discipline.
• Formal training in Validation, Quality Assurance or GxP is highly desirable.
• Experience in EU GMP/GDP regulatory frameworks within pharma/ life sciences.
• Strong understanding of IQ/OQ/PQ and computer system validation (GAMP 5).
• Proven experience managing validation and quality systems in a GxP environment.
• Excellent communication skills for audits and regulatory interactions.

Responsibilities

• Provide management support across qualification and validation topics.
• Manage qualification and validation of equipment, control systems and computer systems for Life Sciences in Ireland.
• Oversee validation activities including thermometric studies relevant to facilities and systems.
• Manage qualification and requalification schedule for GxP-critical equipment and systems.
• Act as the key contact for QA enquiries from clients and audits.
• Assess suppliers for GxP criticality and manage supplier qualification.

Skills

GxP compliance

Quality Assurance

Regulatory audits

CSV

GAMP 5

IQ/OQ/PQ

Leadership

Education

Bachelor’s degree in Science/Engineering/Pharmacy

CSV/GxP training

Tools

WMS

Microsoft Office

Job description

Cpl Group is seeking a QA Validation Manager to lead qualification and validation activities for equipment, control systems and computer systems within the Life Sciences business in Ireland. The role requires a strong background in GxP, EU GMP/GDP, and successful delivery of QA projects.

Applicants should have a Bachelor’s degree in a related field and formal training in Validation or CSV. The position involves management responsibility and collaboration with suppliers, sites, and regulators.