Senior Quality and Validation Specialist

What You Need to Know:

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 company's parent organisation is based in the US, providing strong support and long-term growth potential.

Your New Job:

You will lead validation and qualification activities, ensuring regulatory compliance while supporting the site's set-up. This is a permanent role with a competitive salary and benefits package.

Key Duties and Responsibilities:

1. Ensure compliance with HPRA, Annex 11 & 15, GMP, FDA, EMA, and other regulatory standards.
2. Support the QP on-site in setting up the quality function.
3. Lead validation and qualification of equipment, utilities, facilities, and computerised systems.
4. Develop and execute validation protocols (IQ/OQ/PQ), cleaning validation, and process validation.
5. Oversee the Quality Management System (QMS) and maintain SOPs and work instructions.
6. Conduct internal audits, regulatory inspections, and risk assessments (FMEA).
7. Investigate and close validation deviations, non-conformances, and CAPAs.
8. Provide technical leadership and collaborate with cross-functional teams.
9. Ensure compliance with Good Documentation Practices (GDP) and data integrity standards (21 CFR Part 11, Annex 11).
10. Train and mentor staff on validation principles and quality systems.

What Are We Looking For?

1. Essential experience with HPRA and EU GMP Annex 11 & 15.
2. Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
3. 4-8 years' experience in pharmaceutical or biotech manufacturing, with expertise in validation and quality management.
4. Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
5. Experience with equipment/facility qualification, computerised system validation, and data integrity compliance.
6. Excellent leadership, communication, and problem-solving skills.

Apply for This Job Now

Or get in touch with Tina by email- tina@matrixrecruitment.ie

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