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We are looking for an experienced Quality Engineer to join our team on an initial 9-month contract. This role offers a fantastic balance of remote working alongside a high-performing global team, with just an occasional requirement to attend onsite meetings in Basingstoke (typically once a month). You will be responsible for ensuring quality compliance across our operations, providing essential oversight through detailed documentation reviews, process monitoring, and cross-functional collaboration.
Job Responsibility
Support and maintain compliance with GMP/GxP, ISO standards, and regulatory requirements
Investigate quality events, deviations, and lead root cause analysis efforts
Manage and support change control activities and CAPA processes
Conduct and support both internal and external audits, as well as regulatory inspections
Author, review, and update quality documentation, including SOPs and investigation reports
Perform data analysis, trending, and reporting on key quality metrics
Collaborate with cross-functional teams to drive corrective actions and continuous improvement initiatives
Requirements
Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field
5+ years of experience in quality assurance/quality control within a regulated industry (pharmaceutical, medical device, or biotech preferred)
Candidates with an advanced degree and 3+ years of experience will also be considered
Hands-on experience with Quality Management Systems (e.g., MasterControl, TrackWise, or similar Document Control Systems)
Strong technical writing skills, proven expertise in root cause analysis, and proficiency in statistical analysis/data trending
Solid knowledge of GMP/GxP regulations and ISO standards (such as ISO 9001 or ISO 13485)
Candidates must be eligible to live and work in the UK