Part time Qualified Person (QP)
Our Dublin based client is currently recruiting for an experienced and qualified Qualified Person (QP) on a part-time basis to oversee key quality system requirements and carry out QP certification/batch release for herbal medicinal products. The successful candidate will ensure full compliance with EU Good Manufacturing Practice (GMP) standards, Annex 16 requirements, and national regulatory expectations.

This role offers flexible working arrangements, making it an ideal opportunity for a QP seeking a structured part-time position within a growing health and wellness organisation.

Key Responsibilities:

Batch Certification & Release

• Fulfill all regulatory duties of the Qualified Person as mandated by Annex 16 of the EU Guide to GMP for Medicinal Products.
• Perform QP batch certification and release for herbal medicinal products, maintaining the official QP Register.
• Oversee and ensure the timely completion of Product Quality Reviews (PQRs) for all herbal medicinal products.

• Provide active oversight of the Quality Management System, including key quality subsytems:
• Change Control: Ensure strict adherence to change management procedures for critical operational changes impacting product quality or GMP compliance.
• Deviations & CAPA: Direct oversight of investigations, root cause analyses, and corrective/preventive action implementation.
• Customer Complaints: Review and sign off on customer complaints related to medicinal products.
• Review and approve Standard Operating Procedures (SOPs) concerning herbal medicinal products.

• Oversee supplier approval processes for all medicinal product materials and manufacturing partners.
• Ensure relevant Quality Agreements (Technical, Distribution, Manufacturing, and Supply) are established and maintained with all herbal medicinal product subcontractors.

• Manage relationships with relevant regulatory authorities (e.g., HPRA) to ensure audit Readiness, timely notifications, and compliant regulatory communications.

• Qualified Person (QP) Status: Meets the statutory requirements to act as a Qualified Person as defined in EU Directive 2001/83/EC (or equivalent national regulations).
• Experience: Proven experience operating as a QP, with specific exposure to herbal medicinal products or solid oral dosage forms being highly desirable.
• QMS Expertise: In-depth knowledge of EU GMP guidelines, Annex 16, Product Quality Reviews, and risk-based quality management systems.
• Communication: Strong communication and stakeholder management skills to interact effectively with regulatory authorities and external subcontractors.