Job Description
An exciting opportunity has arisen for a Supplier Assurance Specialist in the pharmaceutical industry. This role, based in Berkshire, will be part of the Global Product Quality team. The Specialist will contribute to the management and maintenance of the quality system to ensure that quality assurance and regulatory compliance activities are fully adequate and compliant with all relevant legislation and industry recommended practices.
Key Responsibilities:
* Supports the management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe.
* Maintains the overall audit schedule of contractors and suppliers based on an appropriate risk assessment and qualification process.
* Performs GxP audits at company partner sites, mainly within Europe.
* Follows up on supplier audit reports and ensures adequate corrective and preventative actions are in place, including advice on and agreement of actions and monitoring their effectiveness.
* Contributes to the development, maintenance, and improvement of supplier management policies, standards, and procedures.
* Participates in supplier development projects and continuous improvement activities focusing on supplier quality.
* Assists in internal audits and regulatory audits and inspections.
* Assists in maintaining an Approved Supplier List and defining areas to be targeted during the assessment or evaluation.
* Tracks supplier quality on a monthly/quarterly basis, identifies supplier non-conformance trends, and implements appropriate supplier actions.
* Contributes to the development and maintenance of the quality system to ensure compliance with GMP and GDP.
* Prepares and maintains GMP documentation, such as standard operating procedures and Quality Technical Agreements.
* Works with suppliers to develop, agree, and document processes.
* Provides support to other functions within the Global Product Quality team, including:
* Conducting training sessions on Quality processes and systems.
* Providing support to regulatory inspections.
* Batch record reviews.
Requirements:
* 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).