Back to jobsAct as second line and program co-owner for new vendors’ introduction, qualification, and assessment.
Act as point of contact for vendors’ notifications for quality related issues and changes.
Oversee the quality oversight program for vendors; in addition to material complaints handling and its close out with vendor.
Act as the site point of contact for service providers’ evaluation, assessment, and qualification.
Ensure that new product launches and new vendors-related changes are deployed correctly and in compliance with regulatory expectation.
Ensure timely manners reporting of potential violation or non-compliance issues to the reporting manager.
Investigate material complaints related to raw and packaging materials
Evaluate corrective and preventive action (CAPA) responses to the assessment findings for adequacy, including root cause and timeliness.
Ensure timely receipt of responses from all applicable vendors. Review Approve and Maintain responses.
Issue and Review contractual agreements (e.g. Quality Assurance Agreements) for vendors, third parties, service providers and CMOs
Review and approve batch record documents, investigations and change controls for CMOs.
Service providers qualification management.
Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.
Handling of deviations and investigations.