Supplier Quality Assurance

Parkside Recruitment; Reading; Hybrid; GBP 80,000 - 100,000; Full time

Job description

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.

Please note that this role is more of a junior role.

We are looking for a high-performing individual who has around 2 years of experience in supplier audit, compliance, and experience of GMP/GDP and management systems.

My client offers an amazing environment for people to be part of high-performing and passionate teams, with the ability to progress and develop new skills and experiences. My client is 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.

Key Responsibilities:

• Contribute to the management and maintenance of quality systems in order to ensure that quality assurance and regulatory compliance activities are fully adequate, complying with all relevant legislation and industry recommended practices.
• Support in the management of suppliers and service providers ranging from manufacturing and automated packaging to distribution activities throughout Europe.
• Support maintenance of the 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 on supplier audit reports and ensure adequate corrective and preventative actions are in place, including 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 licenses and submissions are reflected in the manufacturing, technical, and testing processes and procedures.
• Liaise with suppliers for the management of returned/defective products.
• Assist in collecting, collating, and compiling data for periodic product quality reviews, including preparation of reports.

Required Skills:

• High attention to detail.
• Excellent time management and organisational skills.
• Ability to proactively 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 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.