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