Onsite QA Specialist: GMP & Compliance Focus

Morgan McKinley; Swords; On-site; EUR 60,000 - 80,000; Full time

Job summary

Morgan McKinley is seeking a Quality Assurance professional for an onsite role in Ireland. The successful candidate will provide direct QA support to production, ensure data integrity on the shop floor, and review GMP documentation for accuracy.

You will review electronic batch records, support commissioning and qualification lifecycle documents, and assist with PQ/Process Validation activities, CAPAs, deviations, and audits as part of a cross-functional team.

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3 years of GMP environment experience post-degree.
• Understanding of cGMPs and regulatory requirements.
• Leadership and strong communication skills.
• Ability to coach and upskill a team.
• Analytical aptitude and problem-solving skills.

Responsibilities

• Provide direct quality support to production and support areas.
• Presence on the shop floor to support compliance and data integrity.
• Review and approve GMP documentation/data for accuracy.
• Review and approve electronic batch records and logbooks.
• QA support for commissioning/qualification lifecycle documents.
• QA support for PQ and Process Validation activities.
• Support sustaining and QC activities such as CAPA, deviations, and calibration programs.
• Provide support to internal audits and regulatory inspections.
• Collaborates with cross-functional teams on continuous improvement initiatives.

Skills

Leadership

Communication

Interpersonal skills

Problem solving

Analytical thinking

Education

Bachelor's degree in science or engineering

Job description

Morgan McKinley is seeking a Quality Assurance professional for an onsite role in Ireland. The successful candidate will provide direct QA support to production, ensure data integrity on the shop floor, and review GMP documentation for accuracy.

You will review electronic batch records, support commissioning and qualification lifecycle documents, and assist with PQ/Process Validation activities, CAPAs, deviations, and audits as part of a cross-functional team.