The role is covered in the following locations: Birmingham, Conventry, Dudley, Gloucester, Hereford, Worcester
Fantastic Part-Time Opportunity to join a dynamic and culture focused diagnostics company as a Quality Assurance/Laboratory Manager!
This is a new position within the business providing scope for the right candidate to join the team and make this role their own.
With exposure to senior management from day 1 and an employer fully invested in your own growth and development, this position creates a unique opportunity for a motivated and driven individual to excel within the company.
This role is a permanent, part-time position and will be site based in Worcester.
Candidates with varying levels of experience are encouraged to apply, however this is not an entry level position, you must have some or all of the following skills and experience:
• A science degree in an appropriate subject e.g. immunology, biomedical science, etc.
• In-depth knowledge of and training in Quality Management Standards e.g. ISO13485.
• In-depth knowledge and experience of working with appropriate directives and regulations e.g. Directive 98/79/EC on In Vitro Diagnostic Medical Devices, The Human Medicines Regulations 2012, etc.
• In-depth knowledge and experience of working to Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
• Experience of acting as a Responsible Person as defined in the EU Good Distribution Practice Guide.
• In-depth experience of leading regulatory and other audits.
• Experience of working within a manufacturing environment.
• Experience of liaising with regulatory authorities in the UK, EU and internationally.
Key Duties and Responsibilities
Monitor and maintain the Quality Management System as per ISO13485
Ensures compliance with the In Vitro Diagnostic Medical Devices Directive 98/79/EC where products are CE marked.\ul
Ensures that requirements of GDP `Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)` are met.
• Responsible for review of batch records and ensures the release of manufactured products into stock.
• Responsible for identifying any corrective and preventive action required. This includes handling of customer complaints and issuing of deviations and non-conformance reports.
• Liaise with all departments regarding quality and regulatory issues.
• Lead Management Review meetings with management team.
• Carry out Internal audits
• Ensure that the Medicines and Healthcare products Regulatory Agency (MHRA) requirements regarding the importation and supply of unlicensed medicines are met.
• Liaises with customers and suppliers on quality and regulatory issues.
• Liaises and supports as required company R&D projects researching and informing of regulatory requirements that may pertain to R&D projects.
• Coordinates Health & Safety committee meetings and assists in compliance to UK legal requirements.
• Issues Material Safety Data Sheets and Product Information Data Sheets for products where required.\ul