Job Title: Senior Quality Specialist
Our organization is seeking a skilled Quality Assurance Professional to oversee and maintain our Quality Management System (QMS). As a Senior Quality Specialist, you will be responsible for ensuring the QMS is fit for purpose, managing quality system documentation, and maintaining compliance with regulatory requirements.
This is a permanent position based onsite at our office in Dublin, offering a hybrid work model. The successful candidate will act as a Qualified Person (QP) under EU GMP and Responsible Person (RP) under EU GDP regulations, overseeing and maintaining the QMS and liaising with regulatory bodies.
The ideal candidate will have a strong understanding of GMDPs and regulatory expectations, excellent analytical, communication, and leadership skills, and experience with internal audits and HPRA inspections.
* Key Responsibilities:
* Manage and maintain the Quality Management System (QMS).
* Approve SOPs and quality system documentation.
* Maintain compliance with WDA, MIA, and ASR authorisations.
* Act as QP/RP and liaise with regulatory bodies.
* Support HPRA inspections and prepare written responses.
* Oversee quality aspects of new product introductions.
* Review and approve non-conformances, CAPAs, change controls, and complaints.
* Manage supplier and customer GDP compliance reviews.
* Ensure GMP-compliant batch record review before release.
* Prepare, update, and review technical agreements with partners and third parties.
* Conduct internal audits and management reviews.
* Lead the implementation of continuous improvement initiatives within quality operations.
Requirements:
* Bachelor's degree in Science or equivalent.
* Eligibility to act as a Qualified Person (QP) under Directive 2001/83/EC and 2003/94/EC.
* Minimum 5 years' experience in Quality Assurance within the healthcare industry.
* Strong understanding of GMDPs and regulatory expectations.
* Experience with internal audits and HPRA inspections.
* Excellent analytical, communication, and leadership skills.
What We Offer:
A competitive salary package, opportunities for professional growth and development, and a dynamic and supportive work environment.