GMP Operations & CAPA Specialist

Jobtailor; Dublin; On-site; EUR 42,000 - 64,000; Full time

Job summary

Jobtailor, based in Ireland (Dublin), seeks a GMP Operations Support professional to oversee deviations, CAPAs, change controls, and QRM assessments across manufacturing activities.

You will provide technical guidance, support investigations, and ensure compliance with cgmp standards, documentation, and batch records. This role collaborates with QA, Engineering, and Supply Chain to drive continuous improvements and training materials.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• 1-2 years of experience in GMP manufacturing, quality systems, or operational support.
• Strong working knowledge of cGMP and quality systems (deviations, CAPA, change control, QRM).
• Experience in technical writing and documentation (investigations, SOPs, reports).
• Experience in biologics or regulated pharmaceutical manufacturing highly desirable.
• Exposure to audit and inspection processes highly desirable.
• Lean / Six Sigma knowledge or experience highly desirable.

Responsibilities

• Execute operational support activities, including deviations, CAPAs, change controls, and QRM assessments.
• Act as a subject matter expert in operational support areas such as investigations, documentation, training, or QRM.
• Support investigations, including root cause analysis and identification of corrective and preventive actions.
• Provide day-to-day manufacturing support, including batch record review, on-floor troubleshooting, issue resolution, area release, and readiness activities.

Skills

Deviations Mgmt

CAPA Mgmt

Change Control

QRM Assessments

Batch Record Review

Investigations

Data Integrity

SOP Development

Technical Documentation

Process Improvement

Attention to Detail

Problem Solving

Organizational Skills

Education

Bachelor's degree in Science, Engineering, or related field

Tools

GMP knowledge

Job description

Jobtailor, based in Ireland (Dublin), seeks a GMP Operations Support professional to oversee deviations, CAPAs, change controls, and QRM assessments across manufacturing activities.

You will provide technical guidance, support investigations, and ensure compliance with cgmp standards, documentation, and batch records. This role collaborates with QA, Engineering, and Supply Chain to drive continuous improvements and training materials.