An exciting opportunity to work for a mid Sized Global Pharmaceutical company who are recruiting for a Supplier Assurance Specialist to work as part of their Global Product Quality team based at their offices in Berkshire .
Hybrid working is 2 days per week in the office
Contribute to the management and maintenance of quality systems in order to ensure that quality assurance and regulatory compliance activities are fully adequate, a fully complies with all relevant legislation and industry recommended practice.
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.
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 tracking supplier quality on a monthly/quarterly basis, identify supplier non-conformance 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
Assist in supplier related changes and implementation of required actions to address changes.
Assist in ensuring that the requirements and conditions of the Company's product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.
Assist in collecting, collating and compiling data for periodic product quality reviews, including preparation of reports
Experience in management of GMP/GDP Quality Management Systems
Additional relevant QA experience
Ability to negotiate with third parties on Quality processes