Senior Quality Assurance Systems Specialist

1 week ago

London, Greater London, United Kingdom Cpl Healthcare Full time
Job Description

We are seeking a Senior Quality Assurance Systems Specialist to join our team at Cpl Healthcare.

Salary: Up to £55,000 per annum

Key Responsibilities
  1. System Administration: As the system administrator and vault owner in Veeva Vault (Quality & Clinical), you will support UK and US sites.
  2. User Training and Support: Train, support, and advise Veeva end users on system requirements and workflows.
  3. Troubleshooting and Query Resolution: Responsible for day-to-day troubleshooting and supporting end user queries within Veeva Vault.
  4. Veeva Releases Management: Manage the mandatory Veeva Releases, performing impact assessments and validation via Change Control in order to maintain the system's validated state within strict deadlines.
  5. Configuration and Improvement: Perform continuous improvement activities by designing and implementing configurations within Veeva Vault for new business requirements or proposed changes using Design/Build/Test/Production lifecycle processes.
  6. Validation and Compliance: Participate in authoring and execution, or review and approval of computer software validation testing in accordance with GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance.
  7. Performance Reporting: Create and run reports to support Veeva performance reporting.
  8. Quality Leadership: Be involved with other computer software validation projects as quality lead.
  9. Document Authoring: Author, review, or approve a variety of quality documentation (SOPs, Validation protocols, Deviations, CAPAs, Change Controls).
Essential Skills and Qualifications
  1. A degree in Life Sciences, Engineering, or Computer Science (or equivalent experience).
  2. Experience in a Quality Assurance role.
  3. Proficiency in Veeva Vault, especially Veeva QualityDocs.
  4. Awareness of Computer System Validation.
  5. Knowledge of GxP standards, such as MHRA, FDA, ICH, and GAMP.
  6. Excellent communication and interpersonal skills, enabling comfortable communication at all levels of the business.
  7. Ability to work independently to complete assignments within defined time constraints, while also working collaboratively as part of a team.
  8. Proficient knowledge and understanding of Microsoft Office Applications (Word, Excel, PowerPoint, SharePoint, Teams, Outlook) and/or other relevant software programs.

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