ISR Recruitment
GxP Business Analyst
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GxP Business Analyst
6-month contract
Remote Working
Outside IR35
Market Rates (c£420 per day)
The Opportunity:
ISR Recruitment is currently supporting a confidential consulting programme within a UK Government health organisation to work on a significant GxP e-archive programme, working across business, technical and compliance teams to understand existing processes, identify impacts and risks, refine requirements and develop clear, evidence-based recommendations.
The role would suit a Business Analyst with experience in regulated, highly governed or complex transformation environments, particularly those with exposure to GxP, life sciences, healthcare, data integrity, validation or regulated technology environments.
Skills and Experience:
We are looking for an experienced Business Analyst who can operate confidently across business, technical and compliance environments.
You should have:
- Proven experience working as a Business Analyst within complex transformation, technology or regulated environments.
- Strong experience in requirements gathering, process analysis, stakeholder engagement and impact assessment.
- Experience facilitating workshops involving business stakeholders, technical teams and subject matter experts.
- Strong analytical and problem-solving skills, with the ability to turn complex information into clear recommendations.
- Experience producing high-quality Business Analysis documentation.
- Excellent communication and stakeholder management skills.
- Experience working within a regulated, highly governed or compliance-driven environment.
- The ability to work independently while collaborating effectively across multidisciplinary teams.
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Experience in one or more of the following would be highly advantageous:
- GxP / Good Practice environments / Pharmaceutical or life sciences / Healthcare / Clinical or laboratory environments
- SOP development and remediation
- Data integrity
- Computerised system validation (CSV)
- Quality or compliance programmes
- Regulated data and information management
- Electronic archiving / records management
- Risk assessment and change impact assessment
Role and Responsibilities:
As the Business Analyst, you will work closely with business stakeholders, technical specialists and GxP/Compliance teams to understand current ways of working, assess impacts and risks, refine requirements and support the design of improved processes and services.
You will play an important role in translating complex business, technical and compliance information into clear requirements, actionable recommendations and high-quality documentation.
- Working with stakeholders to understand current processes, ways of working, requirements and business needs, facilitating and supporting workshops with business, technical and GxP stakeholders to gather information, validate findings and agree actions.
- Reviewing existing Standard Operating Procedures (SOPs) and identifying gaps, impacts, required changes and opportunities for improvement; and support the development of recommendations for new or amended SOPs and associated ways of working.
- Leading and maintaining Change Impact Assessments, considering impacts on processes, roles and responsibilities, training and governance to support the refinement of business and non-functional requirements, working closely with technical and GxP specialists.
- Working collaboratively with the Delivery Manager, Technical Architect, Service Designer and GxP Compliance team to contribute to project reporting and key programme deliverables, including the Alpha Report, supporting knowledge transfer and ensure key findings, decisions and documentation are clearly communicated to stakeholders.
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NB: The successful candidate will be required to undergo a basic level of security clearance before undertaking the assignment (one to two weeks’ lead-time).
Applications:
To learn more about this newly created opportunity consulting as a GxP-focussed Business Analyst (GDS) for an initial 6-month temporary engagement, operating on a remote-working basis; please call and speak with Edward Laing here at ISR Recruitment on 07436 071 872 or please send through a copy of your latest online profile and/or CV (edward@isr.uk.com) for an immediate call back in the strictest confidence.
This is a particularly interesting opportunity for a Business Analyst who enjoys working at the intersection of business processes, technology, data and regulatory/compliance requirements within a regulated or highly governed environment and are comfortable working with multiple stakeholder groups; please contact Edward here at ISR to learn more about our client and how they are leading the way in developing the next generation of technical solutions through innovation and transformational technology.
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