CSV Specialist - GMP IT Validation (Hybrid/Travel)

Sharp Services, LLC; Rhymney; Hybride; GBP 45 000 - 65 000; Plein temps

Résumé du poste

Sharp is recruiting a Computerised Systems Validation (CSV) Specialist based at our UK site in Rhymney, Wales. The role supports onsite or hybrid working with regular travel between the UK and European sites in Belgium and the Netherlands.

You will ensure GMP IT systems are properly validated and maintained throughout their lifecycle, reporting to the CSV Quality Manager. Key duties include maintaining the CSV Master Plan, preparing validation documentation, and coordinating validation

Qualifications

• Bachelor’s or master’s degree in information technology or related discipline preferred.
• 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 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 advantageous but not essential.
• Able to travel regularly to Sharp sites in Belgium and the Netherlands.

Responsabilités

• Maintain oversight of all IT systems and their CSV status and ensure validated state throughout lifecycle.
• Maintain the CSV Master Plan and validation procedures, keeping them current.
• Prepare validation documentation including risk/regulatory assessments, test protocols, and reports.
• Plan, coordinate and deliver validation activities with IT, Operations, Supply Chain and Quality teams.
• Document validation activities and results with proper records management.

Description du poste

Sharp is recruiting a Computerised Systems Validation (CSV) Specialist based at our UK site in Rhymney, Wales. The role supports onsite or hybrid working with regular travel between the UK and European sites in Belgium and the Netherlands.

You will ensure GMP IT systems are properly validated and maintained throughout their lifecycle, reporting to the CSV Quality Manager. Key duties include maintaining the CSV Master Plan, preparing validation documentation, and coordinating validation