Main purpose of role:
To ensure process and analytical validation at the manufacturer has been carried out as per current standards and best industry practices in line with Marketing Authorisations (MA).
To obtain existing process and analytical method validation status and review reports as per current standards, highlight any gaps and work with relevant departments on remediation plan to mitigate the risk.
• Maintain and lead activities for the planning and implementation of any analytical and / or process validation master plans for all MA’s held by the company.
• Review and approve validation protocols and reports for upcoming projects.
• Perform detailed validation gap analysis of process and analytical method validations across the range of products under company portfolio as per relevant SOP.
• Highlight any discrepancies / gaps identified in the existing validation, risk assess the identified gaps and propose and lead appropriate remediation activities by liaising with internal / external business partners.
• Support delivery of specific projects including site transfers, API dual sourcing, reformulation and process improvements.
• Maintain inventory for all existing process and analytical validation protocols and reports and ensure SOP is followed throughout the process.
• Support change control process with impact analysis and tasks as required.
• Support QP’s; when required, in their batch release for reviewing key validation documents. To ensure effective communication is maintained with internal customers & external manufacturers.