Job Description
Q&RA EngineerLocation: Basingstoke, with occasional on-site attendance required (approximately once per month for meetings)Pay Rate: £23.50 per hourWe are currently recruiting for a Q&RA Engineer to join a fast-paced and highly regulated manufacturing environment. This role will focus on providing quality oversight through documentation review, process monitoring, investigation support, and collaboration with cross-functional teams to ensure compliance and continuous improvement across quality systems.This is a 9-Month contract with the possibility of an extension.Key Responsibilities:Provide support and maintain compliance with GMP/GxP, ISO, and regulatory requirementsInvestigate quality issues and support root cause analysis activitiesManage and support change control processesConduct and support internal and external audits and regulatory inspectionsAuthor and review quality documentation including SOPs, investigation reports, and related recordsPerform data analysis, trending, and reporting of quality metricsCollaborate with cross-functional teams to drive corrective and preventive actions (CAPA)Support continuous improvement initiatives and quality system enhancementsEducation & Experience:Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years' experience in Quality Assurance or Quality ControlAlternatively, an advanced degree with 3+ years of relevant experiencePrevious experience within regulated industries such as pharmaceutical, medical device, or biotechnology environments preferredExperience working with Quality Management Systems, CAPA processes, deviation management, and change controlStrong understanding of investigation techniques, root cause analysis, and corrective action implementationExperience supporting or hosting internal/external audits and regulatory inspectionsKnowledge of statistical analysis, data trending, and quality metrics reportingProject management experience beneficialKnowledge, Skills & Abilities:Strong understanding of GMP/GxP regulations and ISO standards including ISO 9001/13485Knowledge of risk assessment methodologies and continuous improvement toolsStrong technical writing skills for SOPs, investigation reports, and quality documentationExcellent problem-solving skills and attention to detailStrong verbal and written communication skillsAbility to collaborate effectively across teams and departmentsComfortable working within manufacturing environments and using PPE where requiredAbility to work independently while supporting cross-functional teamsBrook Street NMR is acting as an Employment Business in relation to this vacancy.TPBN1_UKTJ