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Quality Assurance Specialist
1 month ago
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.
Your New Job: You will lead quality and validation activities, ensuring regulatory compliance while supporting the sites set-up.
This is a permanent role with a competitive salary and benefits package.
QA Specialist Responsibilities: Ensure compliance with HPRA, Annex 11 & 15, GMP, FDA, EMA, and other regulatory standards.
Support the QP on-site in setting up the quality function.
Support 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) and maintain 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).
QA Specialist requirements: Essential experience with HPRA and EU GMP Annex 11 & 15.
Bachelors or Masters degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
4-8 years experience in pharmaceutical or biotech manufacturing.
Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
Experience with equipment/facility qualification, computerised system validation is an advantage.
Excellent leadership, communication, and problem-solving skills.
Skills: Quality Assurance Validation pharma Packaging
