Global Supplier Quality Specialist – 5562 (ADA)
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for Global Supplier Quality Specialist for a 6-month contract, with possible extension, based in the Basel, Switzerland.
As a Global Supplier Quality (GSQ) candidate, you will be communicating directly and indirectly with suppliers, client sites, and within their own team. You should demonstrate project/time management capabilities in order to monitor the progress of technical documents and assessments. You will work independently or with minimal guidance from team members. You will be responsible to escalate issues promptly. You should maintain awareness that the documents/assessments they produce affect patient safety, drug quality, and client’s global reputation.
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 client 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. Interact with the suppliers and the sites as needed to complete this activity.
· 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.
Qualifications and Experience:
· Relevant working/residency permit or Swiss/EU-Citizenship required
· Bachelor’s degree.
· 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.