Csv Specialist

Description:

Our client is a leading biotech procurement company who provide purchasing and supply chain management solutions to life science & biotech organisations of all sizes.

They are looking for a Computer Software Validation Specialist to join their growing CSV team!

You could be an experienced CSV Specialist already in the life sciences/biotech/pharma sectors or an experienced quality professional who is heavily involved in CSV and software validations projects in a GMP environment!

If this is you and you are keen to join a collaborative and growing company then please continue reading and apply today!

As the CSV Specialist in this role you will:

• Assess software functionality, identify areas that require validation and conduct risk assessments to identify potential areas of non-compliance.
• Manage the full lifecycle of validation projects, ensuring consistency and quality at every stage.
• Design and develop software validation strategies to ensure regulatory compliance.
• Create detailed validation protocols.
• Oversee validation test cases.
• Maintain all validation documentation.
• Work closely with customers and internal teams.
• Keep up to date with industry regulations to remain compliant.
• Review and optimise validation processes.

Our client is looking for:

• Demonstrable experience of validating GxP software systems in the Life science or Biotech industry.
• The ability to interpret and apply relevant regulations to maintain validation compliance.
• Knowledge of regulatory requirements including FDA 21 CFR Part 11.
• Excellent communication and relationship building skills.
• A track record of managing and delivering projects.
• A willingness to champion validation processes and adherence to regulatory compliance.
• Strong attention to detail.