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 months
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.
- 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
- Work with suppliers for the development, agreement and documentation of processes
- 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.
- Liaise with suppliers for the management of returned/defective product
- Assist in collecting, collating and compiling data for periodic product quality reviews, including preparation of reports
- High attention to detail
- 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
