I am exclusively partnering with an exciting pharmaceutical start-up in Westmeath to hire a Senior Quality Assurance Specialist. This is a unique early-hire opportunity to join a site at the very start of its growth journey, offering exceptional career development and long-term progression for the right candidate.

As one of the first QA professionals on-site, you’ll work closely with the Qualified Person (QP) to help establish and embed the quality function. The site is backed by a successful US-based parent company, providing strong operational support and long-term stability.

Your New Role:

You will lead quality assurance activities, with a focus on compliance, QMS implementation, documentation control, and providing QA oversight of validation processes. This is a permanent position offering a competitive salary and a comprehensive benefits package.

Key Responsibilities:

Quality Assurance & Compliance Focus:

• Act as the primary QA point of contact on-site.

• Support the QP in establishing and maintaining the site’s Quality Management System (QMS).

• Ensure full compliance with HPRA, EMA, FDA, ICH, and EU GMP (Annex 11 & 15) regulations.

• Develop, review, and maintain SOPs, work instructions, and controlled documents.

• Conduct and support internal audits, regulatory inspections, and inspection readiness.

• Lead or support deviation investigations, non-conformances, and CAPAs.

• Promote adherence to Good Documentation Practices (GDP) and data integrity standards (21 CFR Part 11, Annex 11).

• Collaborate cross-functionally on packaging, labelling, and client-specific quality requirements.

Validation Support (Knowledge Required):

• Provide QA support and oversight for validation and qualification activities across equipment, utilities, facilities, cleaning, and computerised systems.

• Review and approve validation protocols (IQ/OQ/PQ) and associated documentation.

• Participate in validation risk assessments and contribute to the Validation Master Plan (VMP).

What We’re Looking For:

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.

• 4–8 years’ experience in pharmaceutical or biotech manufacturing, with a strong background in quality assurance.

• Solid knowledge of GMP, regulatory compliance, and QMS management.

• Familiarity with validation lifecycle principles, including equipment/facility qualification and computerised systems.

• Experience with audits, CAPAs, investigations, and change controls.

• Strong communication, documentation, and collaboration skills.