Quality Assurance Release Specialist
Location: Birmingham, West Midlands
Salary: Up to 30k + Benefits
Do you want to work for a £130m turnover, private equity backed, international healthcare business, which specialises in the development, manufacture and distribution of diagnostic products.
Reporting to the Quality Compliance Manager, the QA Batch Release Specialist is responsible for the review of completed Device History Records (DHRs) to ensure that all standards and regulatory requirements have been met for product release.
Additionally this role will support the wider QA department in ensuring that the quality management system meets all requirements of all relevant regulatory standards and Regulations: (ISO9001/13485, FDA CFR 820 part 21, QSR’s) and supports the manufacture of consistent quality product.
Principal Duties and Responsibilities:
• This post will involve line management of the QA Batch Release team within the Quality Administration Group, including ensuring all members are properly trained for their duties.
• To be responsible for planning own workload without day to day input from Line Manager, influencing personal training and establishing appropriate timelines for long term projects.
• To coordinate workload and set objectives for direct reports to ensure that operative objectives of the department are met and delivered within agreed timescales.
• To be responsible for coordinating staff 1-2-1’s, IPDs, Development plans and for addressing any performance issues for direct reports, and provide assistance and guidance in the management for indirect reports.
• To assist in the assessment of staff for annual pay review
• To assist in the assessment and management of staff (both direct and indirect) performance in relation to Company expectations. Including, where necessary, application of disciplinary or grievance procedures.
• To comply with the Company’s Health and Safety policies for the well-being of all employees within the Company.
• Carry out Device History Record checks at predetermined manufacturing ‘gateways’ to enable kit release.
• Verify information in the DHR meets the requirements for the Device Master Record including correct product specification, correct procedures have been completed, correct ERP product structure and that all NCRs and CAPAs have been appropriately addressed prior to release.
• Act upon the batch release schedule priority, feeding back kit release problems to Manufacturing managers and the Planning Team where appropriate.
• Schedule daily workload of the QA Batch Release Team to ensure timely release of product.
• Record issues and escalate issues appropriately through to Quality Engineers or Manufacturing Managers.
• Maintain and publish KPI’s for the DHR release process.
• Continually work towards making improvements in the release process
- Degree or equivalent in Biological sciences or similar
- Experience in working in a regulated industry
- Supervisory experience
- Functional QA or QC position within a regulated industry
- Currently working in a similar QA release role.
- Good understanding for Quality principles / Quality systems
- Must be able to work and lead in a team environment
- Strong communication skills both written and verbal skills
- Can be self-sufficient and prioritizes work load to business requirements
- Audit experience
- Quality Assurance system background
- Training to ISO 9001/13485 or 21CFR part 820
- Excellent Computer skills
To apply for this role please submit your latest CV or contact Aspect Resources on 0121794 8181