About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist, Validation to join our Quality team.
This role is responsible for overseeing and ensuring that process and analytical method validation activities conducted by contract manufacturers comply with current GMP standards, applicable regulatory requirements, Marketing Authorisations (MAs), and industry best practices. The role also involves identifying validation gaps, assessing associated risks, driving remediation activities, and supporting quality improvement initiatives.
What You'll Be Responsible For
Lead planning and implementation of process and analytical validation master plans for company products.
Review and approve validation protocols and reports for recent projects, including development, technology transfer, and product lifecycle management changes.
Conduct validation gap assessments for process and analytical methods and ensure compliance with relevant SOPs.
Identify validation gaps and risks and coordinate remediation activities with internal teams and external contract manufacturers.
Support quality activities for site transfers, API dual sourcing, reformulation, and process improvement projects.
Review validation batches and provide technical input based on formulation and production experience.
Define CPPs and CQAs based on formulation knowledge and review validation protocols and reports accordingly.
Review analytical methods and validation documents against the latest ICH guidelines and Pharmacopoeial requirements.
Maintain records and inventories of existing process and analytical validation protocols and reports.
Support change control activities by conducting validation impact assessments and recommending required actions.
Support QPs in reviewing key validation documents during batch release, where