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Quality Assurance Deputy Manager

4 weeks ago

Loughborough, United Kingdom fabric recruitment Full time

**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 sectorto 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.

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