Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities.
Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments.
Provide consultative guidance on quality related matters to clients and internal associates.
Document Control Management
Perform pre and post review and approval of production batch records
Perform pre and post review and approval of label printing records
In-Process Check Responsibilities for production and label printing jobs
Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
Responsible for quality compliance of controlled temperature shipments
Approval of components and material specifications
Responsible for the release of client/Fisher supplied materials
Prepare new and update existing job related Standard Operating Procedure (SOPs)
Assist in the QA/GMP training of employees across the company
Participate in departments system development initiatives to improve regulatory and quality efficiency and compliance
15. Perform ad-hoc duties as requested by line management
