Quality Assurance Deputy Manager

Loughborough

up to £40,000 DOE

Fabric Recruitment are proud to be supporting a highly recognised local manufacturer who with their worldwide coverage makes them a leader in their field. Due to continued success, they are now seeking an experienced Manager from the Pharmaceuticals sector to ensure smooth running of the Quality Department.

Description of the role:

• To proactively participate in the continual improvement of the Quality Management System (QMS).
• Liaise between the business and the system service provider for management and implementation of routine upgrades to the Enterprise Resource Planning (ERP) system and electronic Quality Management System (eQMS).
• Ensure that processes including Corrective Action Preventative Action (CAPA), Change Controls, Deviations, Documentation control and Risk Assessments, internally and externally, are maintained and monitored.
• Ensure that the systems for approval/periodic re-approval of both customers, and suppliers, are functioning effectively and correctly.
• Serialisation, issuing, management and maintenance of the Falsified Medicines Directive (FMD) serialisation system.
• Establishing and maintaining the Master File including products, manufacturers and laboratories
• Covering all aspects of training (Matrix, scheduling, approved training materials, approved Trainers, training records).
• Complaints and Recall (logging, investigating, reporting, periodic analysis) system, with maintenance and filing of complaints files.
• Medical Enquiries/Adverse Events recording, and inputting system are maintained with communication and close links to Marketing Authorisation Holder (MAH).
• Technical Agreements (ensuring Technical Agreements with all suppliers are maintained with up-to-date information and there is an annual review for variable information and 3 yearly reviews for the full document.
• External audit (scheduling, planning, reporting, assessment) systems and procedures, providing support with audit preparation and throughout the audit days, as necessary.
• To be involved in audit preparation; and provide support in respect of Annual Product Quality Reviews (APQR) and resolve queries and issues.

About you:

• A working knowledge and practical experience with electronic management systems (preferred: electronic Quality Management Systems (e-QMS), Enterprise Resource Planning (ERP)).
• Experience in Quality Assurance.
• Relevant degree in a life science or technical discipline.
• Excellent communication skills, both verbal and written.
• Excellent organisational and time management skills.
• Good reasoning and a deductive capability.
• Strong stakeholder management skills.
• Experience developing and controlling a budget.

This is a great opportunity to work for a company who truly commit to their employee's development both personally and professionally.