Supplier Qualification, cGMP cGDP, QAA, Process Documentation, GxP
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The Global Supplier Quality candidate will be communicating directly and indirectly with suppliers, company sites, and within their own team.
The employee should demonstrate project/time management capabilities in order to monitor the progress of technical documents and assessments; They will work independently or with minimal guidance from team member. They will be responsible to escalate issues promptly. The employee should maintain awareness that the documents/assessments they produce affect patient safety, and drug quality.
The role will be part of big QAA remediation project to cover missing QAA documentation for those suppliers that fall under this GxP requirement.
In scope of the project, the role will be managing processes and tools, operations and activities enabling supplier qualification at a global level.
The responsible person executes supplier qualification activities deriving from the implementation of global processes and expectations from Health Authorities.
The role supports the supply of materials and services to the organization within area of responsibility by driving the authoring, review and approval of QA agreements (QAA) and other related qualification documents.
- Supplier Lifecycle management for project global QAA remediation to manage end to end QAA establishment process from authoring to signatures and appropriate system upload
- Independently responsible to manage authoring / revision QAA and Supplier Commitment Letters (SCLs) in due time, route for review before initiating approval process.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
- Manage assigned systems and tools in an optimized way to facilitate lean global activities of QAA’s
- Ensure with peers and supervisor, that the assigned project is embedded into the overall concept for the QA Ops owned processes; ensure that process is aligned with systems used by other stakeholders (exchange of data / information, lean process, elimination of redundancies)
- Collaborate closely with management and peers to report on progress for tight timelines of QAA remediation project
- Bachelor’s degree required
- Extensive knowledge in cGMPs and cGDP requirements, ISO standards for supplier qualification and QAA establishment process
- Experience in Supplier Qualification and Supplier Monitoring
- Able to work independently, take risk based decisions and have strong negotiation skills
- Fluent in English spoken and written