QA/CSV Specialist (£50k-£60k per annum plus benefits)

uMotif; London; On-site; GBP 35,000 - 55,000; Full time

Job description

The Role

We seek a motivated and talented Quality Assurance Specialist to join our team in the UK. This is a permanent, full-time role.

The successful candidate will work within our Quality team supporting the implementation of our next generation patient-centric remote clinical trial solutions.

What will you do?

You will be an integral part of our Quality team responsible for ensuring that the development and configuration of our software products is maintained in accordance with GxP rules, regulations, and guidelines.

The role will bring the opportunity to work with the R&D Engineering and Delivery Services teams to facilitate the compliant release of core, and configured software to support the capture and processing of patient and clinician data relating to clinical trials that are performed by our customers.

Core components of the role will include:

• Acting as a quality contact/subject matter expert for Computer System Validation (CSV) and Quality Risk Management for the development of computerised systems throughout the product lifecycle.
• Ensuring that the Validation Strategy supports relevant GxP, Data Protection and Privacy Requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, 21 CFR Part 820, GDPR, HIPAA etc.)
• Reviewing and approving changes to computerised systems through the change control process to assess the impact on the validated state.
• Facilitating the compliance of new computerised software applications to the documented Software Development Life Cycle (SDLC)
• Ensuring that, where required, software applications are validated according to current regulatory requirements, and industry guidance
• Ensuring that IT infrastructure is qualified according to current regulatory requirements, and industry guidance
• Ensuring that there is an up-to-date Validation Plan (VP) in place for each computerised system as defined by the Validation Policy
• Using a risk-based approach to define what qualification stages are required for software applications and hardware infrastructure to ensure compliance with GxP rules, regulations and guidance
• Supporting the drafting, approval, execution and reporting of validation documentation
• Approving Quality documentation on behalf uMotif Limited as required
• Where required contributing to the evaluation of test defects associated with validation and qualification activities
• Ensuring there is a focus on the accuracy and quality of records associated with the validation and qualification of computerised systems, ensuring that entries are recorded on a contemporaneous basis and stored appropriately
• Ensuring that periodic reviews of validated and qualified computerised systems are performed, when required
• Supporting the preparation of key Quality System procedural documents associated with product engineering, and providing advice to other members of staff to ensure that the resulting documented process meets regulatory, and customer requirements

What you need to succeed

ESSENTIAL SKILLS AND COMPETENCIES

• A bachelor’s degree or equivalent in a science subject
• Knowledge of Quality System rules, regulations and practice associated with the development of software systems that are used in regulated life-sciences industries
• Demonstrable competency in the methods used to validate software systems and in facilitating risk assessment discussions gained within a commercial environment
• Good written and verbal communication skills in English
• Proficiency in office systems, e.g. Microsoft Office

Nice to have

• A thorough working knowledge of Atlassian JIRA and/or Veeva QualityOne
• Good personal organisation and problem-solving skills
• A proven ability to work as part of a multi-disciplinary team in a commercial environment
• Strong people skills and the ability to influence others

Candidates with past commercial experience in the clinical trial industry and a detailed knowledge of Good Clinical Practice rules and guidelines will have a distinct advantage.

Why uMotif?

uMotif is an equal opportunity employer

We positively encourage applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

We want everyone at uMotif to be comfortable bringing their true self to work.

That means acknowledging your personality, including the quirky bits, and bringing your interests, hopes, dreams, and even fears with you is fine, even if they don't seem relevant to your work.