A highly successful Healthcare Provider seeks a talented Quality Manager to manage activities within Quality Assurance in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP), as well as associated legislation.
Responsibilities:
* Perform the duties of Quality Manager and deputy Responsible Person on Company's Wholesale Distribution Authorisations (WDA).
* Manage the Quality Compliance and Temperature validation team.
* Manage HPRA Inspections and principal/client audits.
* Manage the activities of a Qualified Person (QP) on Company Manufacturing Authorisations (MIA's).
* Provide Quality management coordination and leadership for continuous improvement of Quality Management System (QMS) Quality Assurance elements.
* Manage the Deviation Management process, conducting timely investigations, identifying root causes, and implementing effective Corrective Action Preventative Actions (CAPAs).
* Oversee the Complaint Management process, including Company Pharmacovigilance for Product Quality Defects and Potential Adverse Events, as well as supporting GDP complaints.
* Manage the QA role of Recall co-ordination, including Field Safety Notices, CIUNs, Mock Recalls, and ensure effective communication throughout; to Responsible Person, Regulator Authority, Supplier, and Customers.
* Ensure effective Training Management processes are implemented for GDP/GMP compliance.
* Coordinate the Change Management process, conducting comprehensive impact/risk assessments and ensuring timely completion of actions.
* Manage the Documentation Management System – author, review, and ensure that documentation is accurate and compliant with regulatory requirements.
* Take responsibility for Sub-Contractor Management for Company GDP activities, ensuring qualification, control, periodic review, and auditing.
* Oversee Product/Supplier/Customer set-up and Bona-Fides.
* Embed QMS Management principles, fostering an agile quality culture within the organization.
* Develop and maintain a comprehensive audit readiness program to ensure internal and external compliance across 4 sites with multiple business entities through the QMS.
Requirements:
* Minimum of 5 years in Quality Assurance in a GMP or GDP environment.
* Formal Certification as a Responsible Person is an advantage, with experience of secondary packaging processes.
* Demonstrated track record in Quality management system improvement.
* Working knowledge of GDP, GMP, and ISO 9001:2015 is beneficial.
* Strong leadership skills, in particular performance management, observational coaching, and mentoring.
* Highly collaborative, with ability to work constructively and positively influence and engage colleagues and internal stakeholders.
* Minimum Bachelor Degree in Life Science essential.