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Job title: QA Manager

Are you a lead or manager within the Quality, Quality Assurance, or Quality Management System experience within a highly regulated environment? An opportunity has arisen for a QA Manager to join a manufacturing organisation based in South Wales.

About the Job:

We require a QA Manager with extensive experience in GMP life science manufacturing, ideally within a pharmaceutical environment, with exposure to drug manufacturing, aseptic filling, packaging or site services equipment, with interest in working within a highly regulated production environment.

In this role you will work interdepartmental as the QA SME, promoting a strong GMP culture within a small team of QA Officers, with aims of fostering an attitude of strong continuous improvement and audit readiness.

Summarised responsibilities:

• Overseeing the QA team, reporting into head of department, and leading cross-functional QA activities to deliver on quality objectives
• Developing and implementing the companies QMS in accordance with ISO 9001, ICH Q10, ensuring compliance is in line with UK Human Medicines Regulations, the Orange Guide, and EudraLex.
• Carrying out risk assessments, conducting audits (internal & external), SOP's, work instructions, and forms or records.
• Showcasing excellent communication skills when dealing with regulatory bodies, external suppliers, and reporting up to head of department and director
• Promoting a continuous improvement culture ensuring audit readiness through cross functional departments
• Showcasing confidence to make suggestions and challenge new ways of doing things to support a new and growing team

About you:

• Qualification in Science (Chemistry, Pharmacy, Biology etc), Engineering, or equivalent Manufacturing experience
• Strong Quality Assurance experience within a GMP environment
• Proficiency in Quality Management Systems, ideally PQS
• Experience dealing with the MHRA, FDA, or EMA
• Previous lead or management experience
• Positive can-do attitude with drive to lead continuous improvement
• Good communication skills

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.