Supplier Assurance Specialist
3 weeks ago
An exciting opportunity has arisen for a Supplier Assurance Specialist within the Global Product Quality team to join a global pharma company based in Berkshire.
Role
This role is to contribute to the management and maintenance of the company quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and that company fully complies with all relevant legislation and industry recommended practice.
Key Accountabilities
- 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 company 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
Skills and Experience
- Degree level plus, further qualification in auditing desirable
- Experience working in a Pharma Quality Role with exposure to auditing
- Excellent written and spoken English
- Industry experience of manufacturing, automated packaging and distribution sites (GMP and GDP)
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