Overview
The GxP Business Analyst will work on a significant e-archive programme within a UK Government health organization, focusing on improving processes across business, technical, and compliance teams. The contractor will engage with stakeholders to assess current workflows, refine requirements, and create actionable recommendations relevant to regulated environments such as life sciences and healthcare.
Responsibilities
- Collaborate with business stakeholders, technical teams, and compliance specialists to gather requirements and validate findings.
- Facilitate workshops to assess current processes and highlight gaps, impacts, and improvement opportunities.
- Review and analyze existing Standard Operating Procedures (SOPs) for compliance and effectiveness.
- Lead Change Impact Assessments to evaluate impacts on processes and training requirements.
- Contribute to project reporting and program deliverables, ensuring clear communication of key findings.
- Produce high-quality documentation that summarizes complex information into clear requirements and recommendations.
Requirements
- Proven experience as a Business Analyst in complex transformation or regulated environments.
- Strong skills in requirements gathering, process analysis, and stakeholder engagement.
- Ability to facilitate workshops with diverse stakeholder groups.
- Analytical and problem-solving skills, adept at distilling complex information.
- Experience producing comprehensive Business Analysis documentation.
- Familiarity with GxP, healthcare, or life sciences environments is highly advantageous.
- Knowledge of Computerised System Validation (CSV) and risk assessment processes is a plus.
- Experience in developing or remediating Standard Operating Procedures (SOPs).