Senior Quality & Validation Specialist Pharmaceutical Start-Up Westmeath I am exclusively partnering with an exciting pharmaceutical start-up in Westmeath to hire a Senior Quality & Validation Specialist.
This is a fantastic opportunity to join a growing site at a pivotal stage, offering excellent career progression for the right candidate.
This is the fifth hire for the site, and you will play a key role in establishing the quality function alongside the Qualified Person (QP).
The companys parent organisation is based in the US, providing strong support and long-term growth potential.
Key Responsibilities of the Senior Quality &
Validation Specialist:
Ensure compliance with HPRA, EU GMP Annex 11 & 15, FDA, EMA, and other regulatory standards.
Support the Qualified Person (QP) in setting up the quality function.
Lead validation and qualification of equipment, utilities, facilities, and computerised systems.
Develop and execute validation protocols (IQ/OQ/PQ), cleaning validation, and process validation.
Oversee the Quality Management System (QMS), maintaining SOPs and work instructions.
Conduct internal audits, regulatory inspections, and risk assessments (FMEA).
Investigate and close validation deviations, non-conformances, and CAPAs.
Provide technical leadership and collaborate with cross-functional teams.
Ensure compliance with Good Documentation Practices (GDP) and data integrity standards (21 CFR Part 11, Annex 11).
Senior Quality &
Validation Specialist Requirements: 4 years + experience in pharmaceutical or biotech manufacturing with expertise in validation and quality management.
Bachelors or Masters degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
Essential experience with HPRA and EU GMP Annex 11 & 15.
Experience with equipment/facility qualification, computerised system validation, and data integrity compliance.
Apply Now Senior Quality &
Validation Specialist Benefits:
Bonus, Healthcare, pension