We are seeking an experienced and motivated
Qualified Person (QP)
to join a team in Sligo. In this role, you will provide
QA oversight
for all activities within the business unit, ensuring that
GMP requirements
are consistently met and upheld.
As a QP, you will hold legal responsibility for
certifying all manufactured batches
against marketing authorization requirements and GMP principles. You will work closely with the
Director of QA
and
Business Unit Leader
to achieve strategic goals, meet customer expectations, and maintain compliance with
FDA, EU, and other relevant regulatory authorities
.
Key Responsibilities
* Certify and disposition all batches manufactured within the business unit.
* Approve all relevant documentation, including batch records, exception reports, validation documents, and product quality review reports.
* Ensure the business unit is
inspection-ready
for regulatory agency visits and that any non-conformances are addressed promptly.
* Guide the investigation, resolution, and disposition of non-conforming materials or products.
* Provide quality expertise for operational excellence (OPEX) initiatives and new product implementation.
* Lead and motivate QA, QC, Product Release, Compliance, and Bioassay teams to maintain GMP compliance.
* Partner with leadership to deliver the company quality plan and adapt to evolving regulatory requirements.
* Assess the quality impact of regulatory changes and implement process improvements as needed.
Qualifications & Experience
* Degree in Pharmaceutical Science or a relevant scientific discipline.
* Recognized
QP qualification
.
* Minimum 5 years' proven experience in a quality-related role within the pharmaceutical or medical device industry.
If you are a proactive, detail-oriented professional with a strong commitment to quality and compliance, we'd love to hear from you.