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We are seeking a detail-oriented Quality Systems and Compliance Officer to join our team in Swindon. In this role, you will play a vital part in ensuring our site remains compliant with Regulatory GMP (Good Manufacturing Practice) and corporate standards. You will be responsible for maintaining the integrity, safety, and efficacy of our products through robust document management and quality system oversight.
Job Responsibility:
Utilize tools such as TrackWise, SAP, and eDMS to manage GMP documents, write change controls, and progress CAPA (Corrective and Preventive Actions) to completion
Maintain a state of inspection readiness and ensure all approved procedures are strictly followed
Oversee the document lifecycle, manage training records, and assist with metrics reporting
Participate in site-wide projects (PPI) to improve operational efficiency and quality standards
Work closely with internal and external stakeholders to meet key performance targets and objectives
Requirements:
A degree in a scientific subject or equivalent professional experience in a regulated industry (QA experience is highly preferred)
A strong understanding of cGMP and basic Quality Management Systems (Deviations, Change Control, SOPs)
Proficient in Microsoft Office (Excel, Analytics, and Power BI are a plus)
Experience with TrackWise or eDMS is advantageous
A "quality-first" attitude with tenacious attention to detail and a proactive approach to problem-solving
Excellent interpersonal skills with the ability to work independently or as part of a dynamic team