Senior Qa Specialist

4 weeks ago

Athlone, County Westmeath, Ireland Matrix Recruitment Group Full time

Senior Quality Assurance Specialist Pharmaceutical Start-up Westmeath I am exclusively partnering with an exciting pharmaceutical start-upin 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, youll 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 sites 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 Were Looking For: Bachelors or Masters degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
48 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.
Apply for This Job Now Skills: Quality Assurance Quality Management Validation Pharmaceutical

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