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 the ISO accreditations. You will require a scientific background, experience with ISO 9001/13485, GMP, QMS, and management experience.
- 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
- 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 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
- Proficient in the use of Microsoft Office software
You must have the right to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 7579
- Posted: 9th January 2023
- Expires: 6th February 2023