Quality Auditor

Dún Laoghaire, Co Dublin
Contract
Full-time

2 days ago

Shift Pattern4 x 12-hour extended day shifts followed by 4 days offRole OverviewThe Quality Specialist provides direct quality support to a designated production area as part of an Integrated Product Team (IPT). Reporting to the Associate Director of Quality Operations, the role is responsible for ensuring product quality and compliance with Good Manufacturing Practices (cGMP) and Good Documentation Practices.This position has a strong shop floor presence, offering real-time quality guidance and coaching to support right-first-time documentation and manufacturing execution. The role also involves reviewing process documentation for accuracy, completeness, and data integrity, supporting batch disposition activities, and contributing to deviation investigations.Key Responsibilities

Review and approve Master Batch Records (MBRs) and Electronic Batch Records (EBRs)
Review executed batch records, logbooks, and production documentation for compliance with cGMP and internal procedures
Maintain active shop floor presence to support compliance, data integrity, and quality culture
Review and approve SOPs, Work Instructions, and controlled job aids
Participate in Tier meetings to escalate issues and support timely resolution with cross-functional teams
Provide QA support for commissioning and qualification lifecycle activities related to capital projects and new equipment
Act as Quality SME for Performance Qualification (PQ) activities including equipment, facilities, utilities, cleaning validation, SIP, and process validation
Contribute as the quality representative on cross-functional projects
Support quality systems including Change Control, Deviations, CAPAs, equipment requalification, and periodic reviews
Assist with internal audits and regulatory inspections
Collaborate with cross-functional teams to drive continuous improvement initiatives
Apply problem-solving tools and support operational excellence initiatives (e.g. MPS)

Experience, Knowledge & SkillsRequired:

Minimum 5 years' experience in GMP manufacturing, Quality Assurance, laboratory, or related pharmaceutical/biotech environment
Strong working knowledge of QA operations within the biotech or pharmaceutical industry
Understanding of cGMP requirements and regulatory expectations
Proven leadership capability with strong written and verbal communication skills
Demonstrated ability to work collaboratively in a team-based environment

Preferred:

Experience with quality systems and GMP documentation authoring/review/approval
Strong analytical, critical thinking, and problem-solving skills
Experience coaching or mentoring team members
Hands-on experience working on a manufacturing shop floor
Familiarity with GMP documentation review and shop floor auditing

Education & Qualifications

Bachelor's degree in a scientific or engineering discipline preferred
Candidates with relevant experience in lieu of a scientific degree will also be considered

Morgan McKinley

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