Qualified Person

Fastnet - The Talent Group; Cork; Hybrid; EUR 50,000 - 80,000; Full time

Job summary

A leading biopharma recruiting firm is seeking an experienced Qualified Person (QP) to join a quality team in Cork. This hybrid role involves taking responsibility for batch certification, ensuring compliance with GMP and authorization standards, and providing technical leadership. Ideal candidates will have 3–5 years of QP experience and a strong background in Quality Assurance within a pharma/biopharma facility.

Benefits

Collaborative setting

Hybrid work model

Advancement in healthcare through innovation

Qualifications

• Minimum of 3–5 years experience as a named QP under an MIA/IMP.
• 5+ years in Quality Assurance within a pharma/biopharma facility.
• Hands-on experience in aseptic/sterile manufacturing.

Responsibilities

• Take full responsibility as QP for batch certification.
• Ensure compliance with GMP requirements and authorization standards.
• Provide technical QA leadership and support audits.

Skills

QP status

Experience in Quality Assurance

Knowledge of EU/FDA GMP regulations

Effective communication

Risk analysis

Job description

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.

Key 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 & Experience

• 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.