The role:

Plan and execute validation activities in line with site validation plans and project timelines.

• Author and maintain validation protocols and reports across multiple validation areas such as:

Cleaning validation

Computerised systems validation

Equipment and utilities qualification

Process validation

• Interpret validation data against predefined acceptance criteria and document outcomes appropriately.

• Execute validation activities while minimising disruption to manufacturing operations.

• Collaborate with cross-functional teams to deliver validation programmes and report outcomes.

• Maintain validated status of systems, processes, equipment, utilities and cleaning procedures.

• Support and participate in site validation projects and cross-functional teams.

• Generate and execute protocols and reports for non-routine quality or validation-related projects.

• Review analytical data generated by the QC laboratory as part of validation activities.

• Maintain and report validation-related KPIs to support quality performance monitoring.

• Support regulatory inspections and internal audits, including completion of corrective actions where required.

• Investigate non-conformances, performing root cause analysis and risk assessment.

• Support the ongoing maintenance of the Site Validation Master Plan (VMP).

• Ensure validation procedures, SOPs and work instructions remain compliant and up to date.

• Review validation documentation where required.

• • Contribute to knowledge sharing and support colleagues across the validation team.