Job Title: High Level Quality Assurance Expert
About the Role:
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, you'll work closely with the Qualified Person (QP) to help establish and embed the quality function.
New Role & Responsibilities:
You will lead quality assurance activities, with a focus on compliance, QMS implementation, documentation control, and providing QA oversight of validation processes. This includes:
* Act as the primary QA point of contact on-site
* Support the QP in establishing and maintaining the site's 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
Key Skills and Qualifications:
To be successful in this role, you'll need:
* A Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field
* At least 4 years of 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 computerized systems
* Experience with audits, CAPAs, investigations, and change controls
What We Offer:
We offer a competitive salary and a comprehensive benefits package, including professional development opportunities and a supportive team environment.
How to Apply:
If you're passionate about quality assurance and want to be part of a dynamic team, please submit your application. We look forward to hearing from you!
Skills:
Quality Assurance, Quality Management, Validation, Pharmaceutical