Qualified Person

4 weeks ago

Cork, Ireland Fastnet Full time

Overview Qualified Person (QP) | Hybrid | 12-Month Contract
Ready to make an impact in a dynamic, fast-paced biopharma environment?
We're looking for an experienced Qualified Person (QP) to join a high-performing quality team based in Cork. This hybrid contract role (12 months) offers the opportunity to contribute to the safe and compliant release of both commercial and clinical drug products-with a focus on sterile manufacturing and biologics.
Responsibilities Take full responsibility as QP for batch certification in line with EU Directives (2001/83/EC, 2001/20/EC) and Annex 16/13 as applicable.
Ensure product release meets GMP requirements and complies with Marketing Authorisation (MA) or Clinical Trial Authorisation (CTA) standards.
Provide technical QA leadership, ensuring robust compliance across manufacturing and supply processes.
Support internal audits and regulatory inspections (HPRA, FDA, etc.), and represent Quality in cross-functional teams.
Participate in management reviews, continuous improvement initiatives, and oversee Product Quality Reviews (PQRs).
Monitor and promote adherence to site licenses and GxP regulations.
Qualifications QP status with a minimum of 3–5 years experience acting as a named QP under an MIA/IMP MIA.
5+ years in Quality Assurance within an EU-licensed pharma/biopharma facility.
Hands-on experience in aseptic/sterile manufacturing, biologics, or clinical trial materials is highly desirable.
Proven track record in regulatory inspection readiness, technical writing, and quality system oversight.
Strong knowledge of EU/FDA GMP regulations and global quality standards.
Effective communication, mentoring, and decision-making skills.
Ability to analyze risk and drive effective, compliant solutions.
Why Join Be part of a company that’s passionate about advancing healthcare through innovation.
Gain experience across clinical and commercial operations in a supportive, collaborative setting.
Work in a hybrid capacity, balancing on-site influence with flexibility.

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