I am recruiting 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 a solid background 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 months .
They offer hybrid working with 2 days per week in the office High attention to detail Very good written and spoken English Excellent time Management & organisational skills Ability to pro-actively identify issues and seek resolution Experience in management of GMP/GDP Quality Management Systems Additional relevant QA experience Excellent written and verbal communication skills Ability to learn quickly and adapt quickly to changing requirements Ability to work to tight deadlines Good problem solving skills Must be able to handle sensitivity and confidentiality levels appropriately.
Ability to negotiate with third parties on Quality processes Based at the UK office, with significant travel, mainly in Europe, but also in Asia and North America.
The position requires up to 50% travel; mostly European with occasional long-haul travel.
Contribute to the management and maintenance of the quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, 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 GDP Prepare and maintain GMP documentation such as standard operating procedures and Quality Technical Agreements