We are seeking a Quality Associate who will provide Quality support/oversight to Oval Medical Technologies in ensuring key Quality processes are documented, monitored and maintained in line with business requirements relating to device development and in accordance with ISO13485 requirements and the Quality Management system.
This role will also provider broader QA support for Cambridge Pharma Limited (CPL) activities when workload allows, including training, supplier management and documentation control.
Key Responsibilities:
- Ensure that the Quality Management System complies with all aspects of ISO13485 requirements
- Ensure ongoing compliance with both company procedures and external regulatory requirements.
- Ensure key Quality Metrics (KPIs) are compiled for the site and for inclusion in Management Review
- Work closely with project teams to ensure that medical devices development projects are managed in compliance with all relevant regulatory and customer requirements
- Support the implementation, monitoring and development of quality assurance processes and procedures within a culture of continuous improvement
- Support the internal audit process
- Support as required during site customer and regulatory audits / inspections
- Manage and assist with equipment calibration activities. Ensure that up to date records of calibration activities are maintained and available for reference
- Responsible for overseeing key QA systems for device development, including NCR, CAPA, Change Control and Supplier Management
- Assist with safety risk assessments
- Assist with supplier quality management
- Responsibility for companywide document archiving activities
- Support other QA activities relating to CPL activities as required
- Keep up to date with relevant GMP and Medical Device legislation
What we are looking for?
- Understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach
- Exposure to cGMP regulations related to CSV including CFR 21 Part 11, GAMP 5 and Data Integrity
- Minimum of 2 years’ experience working within Pharma/Medical/Biotech or similar GMP environment
- Knowledge of networking and information transfer systems, such as, SCADA and Enterprise systems.
- Validation experience within automated systems
- Good understanding of general manufacturing activities and automated assembly
- A postgraduate qualification in project management or an automation, IT or Computer Science discipline would be advantageous
About You
We are looking for the following:
- An understanding of GMP, ISO13485, ISO14971 and other applicable standards e.g., ICH, PICS
- Minimum two years’ experience in a quality system environment
- Excellent presentation skills for delivery of Quality Metrics
- Good verbal and written communication skills
- Sound reasoning and clear thinking
- Good decision-making ability
- Science related degree or relevant experience preferable
It would be Desirable to Have
- Previous experience with ERP systems
- Auditing skills and experience
- Experience of drug device combinations
- Knowledge of sterilisation and/or manufacturing within an aseptic environment
We are also seeking the following:
- Excellent levels of attention to detail
- Good influencer and negotiator
- Ensures the necessary standards are met whilst being fair and pragmatic with a balanced approach
- Comfortable working with different departments to help and support them in understanding their responsibilities and requirements in respect to ISO13485 and GMP requirements
- Proactive approach to managing tasks and seeking opportunities to improve processes and documentation
To apply
If you are interested in applying for this position, please send a CV and covering letter setting out why you would be suitable for this role, to careers@cambridgepharma.com with the subject line “Quality Associate”