Quality Officer

Hobson Prior are currently working with a leading biopharma organisation who are seeking a Quality Officer to join them on a permanent basis in London. As the Quality Officer you will be responsible for assisting with the management of the quality systems used to ensure all impacted computerised systems are maintained in a validated state.

Job Responsibilities:

• 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.
• 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.

Key Skills:

• Computer literate, e.g. Microsoft Word, Excel, PowerPoint, Project, and Visio.
• Ability to build and maintain solid working relationships and communication links within the organisation and third-party contractors.

Requirements:

• Graduate in Life-Sciences subject (e.g. Chemistry, Biology, Pharmaceutical Sciences, Pharmacy…) or a Computer Sciences discipline.
• A minimum of 3+ years experience of applying quality systems and computer system validation strategies in regulated software development industries.
• Maintain competence in GxP via self-learning, intercompany collaboration, and attend appropriate external training courses and seminars.
• Good Clinical Practice (GCP) knowledge.
• Knowledge of ISPE GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems.
• Knowledge of Quality System, Medical Device regulations would be an advantage (e.g ISO9001, ISO13485).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.