Sharp Clinical Services
Computerised Systems Validation Specialist
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Job Title: Computerised Systems Validation Specialist
Department: Quality
Location: Onsite/Hybrid – Rhymney, Wales
Summary:
Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we have supported pharmaceutical and biotechnology clients from phase I clinical trials through to commercial launch and lifecycle management. Our network includes facilities in the United States, the United Kingdom, Belgium and the Netherlands, together with more than 30 clinical depots providing global coverage.
We are pleased to be recruiting a Computerised Systems Validation (CSV) Specialist based at our UK site in Rhymney, Wales. This role offers onsite or hybrid working, with regular travel required between the UK and our European sites in Belgium and the Netherlands.
The Computerised Systems Validation Specialist will ensure that all IT systems affecting Good Manufacturing Practice (GMP) are appropriately validated and remain in a validated state throughout their lifecycle. The postholder will report to the CSV Quality Manager.
Duties and Responsibilities:
- Maintain oversight of all IT systems and their CSV status. Manage and monitor the validated state of each system, ensuring that software and hardware modifications, changes and updates are assessed through the appropriate CSV process.
- Maintain the Computerised System Validation Master Plan and all associated validation procedures, ensuring that they remain accurate, current and aligned with applicable requirements.
- Maintain an up-to-date inventory of GMP-critical computerised systems, including each system’s owner, intended use and current validation status.
- Prepare validation documentation for GMP computerised systems, including risk assessments, regulatory assessments, test protocols and validation reports.
- Plan, coordinate and deliver validation activities in consultation with colleagues in IT, Operations, Supply Chain, Technical Services, Quality Assurance and Engineering, as appropriate.
- Document validation activities and results accurately and completely, with responsibility for records relating to computerised systems validation.
- Contribute to the continuous improvement and optimisation of people, processes, systems and procedures.
- Assess validation requirements arising from proposed changes to systems, processes, installations or equipment, with responsibility for computerised systems and artwork management and control systems.
- Support and, where appropriate, conduct internal audits across the relevant sites to identify opportunities to strengthen quality standards.
- Act as the subject matter expert for CSV during external audits and regulatory inspections.
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Competencies:
- Demonstrates initiative and a proactive approach to delivering results.
- Takes ownership of responsibilities and follows actions through to completion.
- Able to organise and prioritise work independently while collaborating effectively as part of a team.
- Uses sound judgement and takes a considered approach to decision-making.
- Applies analytical thinking, considers different perspectives and remains open to alternative solutions.
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Requirements (essential unless otherwise stated):
- A bachelor’s or master’s degree in information technology or a related discipline is preferred.
- Demonstrable experience in a pharmaceutical manufacturing or production environment.
- Experience of planning, delivering and overseeing computerised systems validation or other validation studies.
- Working knowledge of GMP requirements and relevant pharmaceutical regulations and guidance.
- Experience of working with quality management systems, controlled procedures and regulated training processes.
- Proficient in Microsoft Office applications and able to produce clear, accurate documentation.
- Dutch language skills, both written and spoken, would be advantageous but are not essential.
- Experience of preparing clear, accurate validation reports and technical documentation.
- Able to travel regularly to Sharp sites in Belgium and the Netherlands, as required.
General:
This job specification is not exhaustive and may be amended to reflect changing organisational requirements following discussion with the postholder.
All employees are expected to understand and fulfil their responsibilities for health and safety, and to treat colleagues with dignity and respect in the workplace.
Sharp is committed to being an equal opportunities employer and to building a diverse and inclusive workforce. We welcome applications from all suitably qualified candidates, regardless of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex, or sexual orientation.
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