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Senior Quality Assurance Professional
2 weeks ago
About the Company
We are a leading recruitment agency, Matrix Recruitment Group, dedicated to providing high-quality candidates for various industries. Our team is passionate about helping businesses grow by connecting them with talented professionals.
Job Description
As a Senior Quality and Validation Specialist, you will play a pivotal role in establishing the quality function at our client's site in Westmeath. This is an exciting opportunity to join a growing pharmaceutical start-up and contribute to its success.
Your Key Responsibilities
- Ensure regulatory compliance with HPRA, Annex 11 & 15, GMP, FDA, EMA, and other relevant standards.
- Support the Qualified Person (QP) in setting up the quality function and lead validation and qualification activities.
- Develop and execute validation protocols, cleaning validation, and process validation for equipment, utilities, facilities, and computerised systems.
- Oversee the Quality Management System (QMS) and maintain SOPs and work instructions.
- Conduct internal audits, regulatory inspections, and risk assessments.
- 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.
- Train and mentor staff on validation principles and quality systems.
Requirements
- Essential experience with HPRA and EU GMP Annex 11 & 15.
- 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 expertise in validation and quality management.
- Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
- Experience with equipment/facility qualification, computerised system validation, and data integrity compliance.
- Excellent leadership, communication, and problem-solving skills.