QA Assistant Validation
Specialists in producing highly sensitive and specific antibodies for the detection of certain cancers, my client provide in-vitro diagnostic test kits to hospitals and clinical laboratories globally.
My client is moving from strength to strength and have now established themselves as the world leading company for this area of clinical testing with global revenue exceeding £80,000,000 in their previous year.
Working as a QA Assistant your responsibilities will include:
• Ensuring all Equipment Qualification and Process Validation is carried out in line with Company Policy & Procedures.
• To assist with Validation of IFS and other Software systems.
• Generate User Specification Requirements (USRs), Validation Protocols/Reports to Company Standards.
• Reporting any issues with Data/Results obtained and assisting in finding solutions.
• Preparing and delivering documentation for validation projects. Ensuring validation is carried out to schedule, that any issues are reported in a timely fashion and that all documentation follows company templates.
• Carrying out validation trials following Installation and Operation Qualifications protocols documented, and documentation of results. Reviewing and approving of the same documentation for other operators.
• Carrying out Performance Qualification/Process Validation trials and documenting results. (Including appropriate data analysis).
Knowledge and Skills
• Working knowledge of FDA Part 820 and ISO13485
• Working knowledge of computer software validation, FDA Part 11 and GAMP5
• Experience of working within a Validation or Manufacturing Environment
• Experience of working with IVDs or Medical Devices
• Knowledge of cGMP
• Good Data analysis skills
• Good report writing skills
You will be open, friendly and professional with an excellent eye for detail. Having an inquisitive mind and the flexibility to cope with changing priorities would be advantageous. You will be able to understand and follow procedures and processes.
Salary is negotiable on experience
This is an opportunity to join a global leader in clinical testing, to be part of a professional team and make a tangible difference in real world medication.
For more information and a confidential discussion, please contact Kieran Whittaker on the below: -
Tel: 0161 923 8174