A computer software company is advertising a vacancy for a QA Officer in their office in London. The organisation provides industry leading expertise in Real World and non-interventional studies whilst working with top pharma, CROs, and e-clinical platforms. This is an exciting opportunity to work with an organisation and provide real QA experience.
- Perform due diligence checks and ensure that suppliers of services or software products are qualified.
- Perform the quality activities associated with Computer System Validation (CSV) and Quality Risk Management for computerised systems in a software development environment.
- Review and approve changes to computerised systems through the change control process to assess the impact on the validated state.
- Ensure that, where required, software applications are validated according to current regulatory requirements.
- Facilitate the drafting, approval, execution, and reporting of validation documentation as required.
- To assist with the qualification of IT infrastructure, as implemented in a cloud computing architecture, according to current regulatory requirements.
- To provide quality support during the definition of what qualification/validation stages are required for software applications and hardware infrastructure to ensure compliance with GxP rules, regulations, and guidance.
- Provide quality support as required to facilitate investigation and resolution of testing deviations associated with the qualification and validation of company software and infrastructure solutions.
- Assist in customer / regulatory audits as required.
- To assist with performance of periodic reviews of the validation and qualification status of computerised systems.
- Assist with the resolution of Corrective and Preventative Actions (CAPA) to ensure appropriate investigations are carried out and remedial actions implemented in a timely manner.
- To assist with the generation of Quality Management System Indicator metrics for review by management.
- To assist with the development of processes to facilitate the company obtaining a 'CE' mark status.
- To maintain documentation associated with information governance in a current state.
- To maintain documentation associate with HIPPA requirements in a current state.
Skills and Requirements:
- Graduate in Life-Sciences subject (e.g. Chemistry, Biology, Pharmaceutical Sciences, Pharmacy…) or a Computer Sciences discipline.
- At least 3 years of experience in applying quality systems and computer system validation strategies in regulated software development industries.
- Good Clinical Practice (GCP) knowledge.
- Knowledge of Medical Device regulations would be an advantage.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.