Job title: Quality Assurance Officer

We are delighted to be offering the Full-time permanent position of Quality Assurance Officer for our Central London Based Client reporting directly to Quality Assurance Director.

As a Quality Assurance Officer you will embrace our client's mission to put patients at the centre of research by building data capture solutions people love to use. Designed with patients for patients, our client's platform supports data capture for each phase of clinical research across all therapeutic areas with e-consent, symptom, eCOA, ePRO, and wearable device data.They are Industry leaders in engaging patients and fast deployments, working with top global pharmaceutical companies to power large real-world evidence (RWE) and virtual studies.

Here's an idea of what you will be doing!

The Quality Assurance Officer is responsible for assisting with the management of the quality systems used to ensure all impacted computerised systems are maintained in a validated state in accordance with the requirements of GxP rules, regulations and guidelines, and industry standards.

You will work with the QMS Specialist and other departments to prepare, review, and maintain quality policies, and procedures, associated with the qualification and validation of computerised systems for the pharmaceutical and medical device industries.

Some of your Responsibilities as a Quality Assurance Officer

Quality Management System (QMS) - to follow, review, and assist with improvements to the QMS, ensuring the following activities are carried out:

- Implementing and maintaining policies to control the validation of software applications and the qualification of cloud based infrastructure in a software development environment QA Operations - to assist the delivery of the following activities:

- Perform due diligence checks and ensure service and software product suppliers are qualified

- Perform 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

- Assist with the qualification of IT infrastructure, as implemented in a cloud computing architecture, according to current regulatory requirements

- 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 uMotif software and infrastructure solutions

- Assist with customer / regulatory audits as required

- Focus on the accuracy and quality of records associated with the QMS ensuring record entries are done on a contemporaneous basis and that records are stored appropriately

- Assist with performance of periodic reviews of the validation and qualification status of computerised systems. This will include uMotif software and infrastructure solutions, and third party software used as part of the software development life cycle

- 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

- Assist with generating QMS indicator metrics for review by management - Assist with developing processes to facilitate uMotif obtaining a 'CE' mark status

Information Privacy and Security - to maintain the following:

- Documentation associated with information governance in a current state

- Documentation associated with HIPPA requirements in a current state

Thinking about applying? You should recognise yourself here!

- Computer literate, e.g. Microsoft Word, Excel, PowerPoint, Project, and Visio

- Graduate in Life-Sciences subject (e.g. Chemistry, Biology, Pharmaceutical Sciences, Pharmacy...) or a Computer Sciences discipline

- 3yrs+ experience of applying quality systems and computer system validation strategies in regulated software development industries

- Build and maintain solid working rela