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 .We are looking for a high performing individual who has around 2 years experience in supplier Audit , compliance and experience of GMP/GDP and management systems .My client offer an amazing environment for people to be part of high performing and passionate teams, ability to progress and develop new skills and experiences . My client are also in a period of growth with new products coming to the market over the next 24 monthsHybrid working is 2 days per week in the officeContribute 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.Perform GxP audits at 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.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 GDPPrepare and maintain GMP documentation such as standard operating procedures and Quality Technical AgreementsWork with suppliers for the development, agreement and documentation of processesAssist 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.Liaise with suppliers for the management of returned/defective productAssist in collecting, collating and compiling data for periodic product quality reviews, including preparation of reportsHigh attention to detailExcellent time Management & organisational skillsAbility to pro-actively identify issues and seek resolutionExperience in management of GMP/GDP Quality Management SystemsAdditional relevant QA experienceExcellent written and verbal communication skillsAbility to learn quickly and adapt quickly to changing requirementsAbility to work to tight deadlinesGood problem solving skillsMust be able to handle sensitivity and confidentiality levels appropriately.Ability to negotiate with third parties on Quality processes
Job Title
Supplier Quality Assurance