Job Title
A Supplier Assurance Specialist is sought to contribute to the management and maintenance of a global pharma company's quality system.
Role Overview
This role involves supporting the management of suppliers and service providers, maintaining an audit schedule, performing GxP audits, and following up on supplier audit reports.
Key Responsibilities
* Support the management of suppliers across manufacturing, automated packaging, and distribution sites in Europe.
* Maintain an overall audit schedule for contractors and suppliers based on risk assessment and qualification processes.
* Perform GxP audits at partner sites within Europe.
* Follow up on supplier audit reports and ensure corrective actions are implemented, including agreement on actions and monitoring their effectiveness.
* Contribute to the development, maintenance, and improvement of supplier management policies, standards, and procedures.
* Participate in supplier development projects and continuous improvement activities focusing on supplier quality.
* Assist in internal audits and regulatory audits and inspections.
* Assist in maintaining an Approved Supplier List and defining areas for targeting during assessments or evaluations.
* Track supplier quality monthly/quarterly, identify trends, and implement appropriate supplier actions.
* Identify and leverage best practices across supplier qualification, surveillance, process, and quality management system audits.
* Contribute to the development and maintenance of the quality system to assure compliance with GMP and GDP.
* Prepare and maintain GMP documentation, such as standard operating procedures and Quality Technical Agreements.
* Collaborate with suppliers to develop, agree, and document processes.
* Assist in managing supplier-related changes and implementing required actions.
* Liaise with suppliers to manage returned/defective product.
Requirements
* Degree-level education plus; further qualifications in auditing desirable.
* Experience working in a Pharma Quality Role with exposure to auditing.
* Excellent written and spoken English.
* Industry experience of manufacturing, automated packaging, and distribution sites (GMP and GDP).
Estimated Salary Range:
£60,000 - £80,000 per annum, depending on experience.