QP – Dublin

Desired Skills: qualified person,qp,batch release

PE Global is currently recruiting for a Qualified Person on behalf of our client based in North Dublin:

This is a position within the Global Product Supply (GPS) Pharma Product Development (PD) Quality organisation that is responsible for the oversight of CSC Quality activities including CSC Logistics EMEA/ASIA PAC operations. The position is responsible for EU Qualified Person (QP) certification and release activities for supply to clinical trials, audit of internal GMP systems/processes and suppliers/third party contractors, as well as assisting stakeholders with regulatory advice and preparation for and management of regulatory agency inspections. This position provides support for the identification and resolution of critical quality issues

Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to:
• Review and approval of QA/QP related procedures
• Support preparation and approval of training materials
• Support review and approval of Quality Agreements
• Ensure knowledge transfer from current release site
• Support Manufacturer(s)/Importation Authorisation submissions as required

Support sustaining operations, including but not limited to:
• Qualified Person release of IMP’s in accordance with procedures and regulatory requirements
• Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
• Advise stakeholders on quality issue management and process enhancement/compliance, ensuring consistent quality standards and fostering strong working relationships
• Incorporate global regulatory trends and changes into Supply Chain Quality.
• Support Site Master File maintenance
• Oversee Manufacturer(s)/Importation Authorisation update and maintenance
• Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
• Review and approve procedural documents
• Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• May influence the external environment through interactions with regulators, trade associations, or professional societies
• Proactively identify risk areas
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Supervise QA personnel as assigned
• Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
• Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives

Reporting Relationship: The position reports to the Director, Clinical Supply Chain Quality – Qualified Person in the CSC Quality Dublin team. The position can be a designee for the Director / Associate Director, Clinical Supply Chain Quality (QP) when required.

Skills/Qualifications
• A degree in science, engineering or related discipline is essential along with 10 years’ experience in a role within the biopharmaceutical/pharmaceutical industry
• Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
Previous experience of Qualified Person release on Investigational Medicinal Products (IMPs) preferred
• Previous experience as a Responsible Person on a WDA desirable
• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
• Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
• Proven clear communication supporting delivery for the business
• Fosters a culture in which people continually work to improve services, and work processes

Travel: This position requires up to 10% of travel

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net