Job Description
An exciting opportunity has arisen for a Pharmaceutical Supplier Auditor to join our team at Parkside Recruitment.
This role is to contribute to the management and maintenance of quality assurance and regulatory compliance activities within the Global Product Quality team. The successful candidate will ensure that company fully complies with all relevant legislation and industry recommended practice.
Key Accountabilities:
1. Support in the management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe
2. Support maintenance of overall audit schedule of contractors and suppliers based on an appropriate risk assessment and qualification process
3. Perform GxP audits at partner sites, mainly within Europe
4. Follow-up of supplier audit reports and where required ensure adequate corrective and preventative actions are in place
5. Contribute to the development, maintenance and improvement of supplier management policies, standards and procedures
6. Participate in supplier development projects and continuous improvement activities focusing on supplier quality
7. Assist in internal audits and regulatory audits and inspections
8. Assist in the maintenance of an Approved Supplier List and define areas to be targeted during the assessment or evaluation
9. Assist in tracking supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions
10. Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits
11. Contribute to the development and maintenance of the quality system to assure compliance with GMP and GDP
12. Prepare and maintain GMP documentation such as standard operating procedures and Quality Technical Agreements
13. Work with suppliers for the development, agreement and documentation of processes
14. Assist in supplier related changes and implementation of required actions to address changes
15. Assist in ensuring that the requirements and conditions of product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures
16. Liaise with suppliers for the management of returned/defective product
17. Assist in collecting, collating and compiling data for periodic product quality reviews, including preparation of reports