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- Supplier Assurance Specialist - Global Product Team
- Hybrid Working
- Support in the management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe
- Support maintenance of overall audit schedule of contractors and suppliers based on an appropriate risk assessment and qualification process.
- Perform GxP audits at company partner sites, mainly within Europe.
- Follow-up of supplier audit reports and where required ensure adequate corrective and preventative actions are in place. Includes advice on and agreement of actions and monitoring the effectiveness of those actions.
- 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 the maintenance of an Approved Supplier List and define areas to be targeted during the assessment or evaluation.
- Assist in tracking supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.
- 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
- Work with suppliers for the development, agreement and documentation of processes
- Provide support to other functions within the Global Product Quality team, such as:
- Conducting training sessions on Quality processes and systems
- Providing support to regulatory inspections
- Batch record reviews
- Degree level plus, further qualification 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)
