Quality Manager/Deputy RP
A highly successful Healthcare Provider has a requirement for a talented Quality Manager to join the team.
You will have responsibility for managing activities within Quality Assurance in accordance with the requirements of the Quality Management System, and in particular in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) and associated legislation. RP qualification is preferred.
Responsibilities:
- Perform the duties of Quality Manager and deputy RP 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 QMS Quality Assurance elements.
- Manage the Deviation Management process, conducting timely investigations, identifying root causes, and implementing effective 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 RP 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
Apply:
Send CVs in confidence to [email protected]
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