QA Manager
2 weeks ago
An established laboratory diagnostic company is looking for a QA Manager to join their team. You will be responsible for the overall development, implementation, and maintenance of the organisation's Quality Management Systems along with maintaining theISO accreditations. You will require a scientific background, experience with ISO 9001/13485, GMP, QMS, and management experience.
The Role
- Overall development, implementation, and maintenance of the organisation's Quality Management system
- Responsible for maintaining ISO9001 accreditation.
- Management of staff training records and matrices
- Management of the company document control system and ensuring it is fit for purpose: e.g., issuing documents for change, new document numbers and reviewing the content, format, and accuracy, etc.
- In collaboration with the Management Team, drive continuous improvement and best practices in
Quality systems
- Maintenance and follow-up of CAPAs
- Management and planning of the internal audit programme and conducting internal audits.
- Identifying and ensuring compliance as far as practically possible with all applicable UK, EU and worldwide standards, regulations, and directives about the development, manufacture, and sale of the company products
- Interaction with regulatory agencies, industry organizations, consultants, suppliers, and legal counsel, when necessary
- Maintenance of product dossiers and ensuring all documentation relating to regulatory issues relating to compliance product registration, shipping, etc. are in place and available as required.
- In conjunction with the R&D department, ensure that compliance with current quality and regulatory standards is applied to all new products or when significant changes are made to existing products.
Experience Required
- Experience in ISO 9001/13485
- QMS implementation and management
- Previous experience with science-based based environment
- QMS auditor training is essential.
- Previous line management and/or supervisor experience
- Excellent interpersonal and communication skills
- Problem-solving skills.
- Strong Planning and organisational ability
- Excellent attention to detail
- Flexibility
- Adaptability
- Proficient in the use of Microsoft Office software
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