Job Title

OverviewCheck out the role overview below If you are confident you have got the right skills and experience, apply today.Onyx Scientific are looking for a Quality Assurance Officer to join our fantastic QA team.The successful candidate will ideally have a degree which is analytical chemistry or chemistry based. They will have experience in most modern analytical techniques such as HPLC, GC, FT-IR, LC-MS and wet chemistry techniques.The ideal candidate will be self-motivated and able to work with minimal supervision. Good interpersonal skills, both verbal and written, are essential for working with colleagues.The successful candidate will be work within the GMP and safety guidelines set by the company. They will assist the Quality Assurance Manager in ensuring the company Quality Management System (QMS) is maintained and complies with the requirements of Good Manufacturing Practice (GMP) as described in the current EU and ICH guidelines. They will perform routine duties with full supervision.They will have a basic understanding of the daily requirements of the department to aid in its efficient running. They will liaise with senior staff within QA and other departments where required.Key ResponsibilitiesPerform QA reviews of PRS/PAR/logbooks/stability studiesPerform QA reviews of Reference standard packsPerform QA reviews of equipment qualification documentsBasic understanding of ALCOA++, GDocPPerform visual inspection of equipment/areaIssue of processing documentationIssue of logbooks, SOPsPerform generation of change controls and NCRsPerform scanning/filing/logging activities (if required)Perform archival of documentation (if required)Perform review of analytical data on Openlab 2.7 under supervisionReview of EM data under supervisionReview of Temperature mapping data under supervision.Key Skills and QualitiesBasic understanding of cGMP, ICH, Eudralex Volume 4 Part IIAble to demonstrate basic problem-solving skills and can identify potential issuesAble to communicate appropriately and effectively with colleaguesGood attention to detailFamiliarity of analytical techniques (if appropriate), their applications, and roles within the company.Able to use initiative, multi-task and plan work effectively to meet strict deadlinesA flexible approach to working additional hours when requiredComputer literate, familiar with Microsoft Word and ExcelWork effectively as part of a team, showing resourcefulness and reliabilityGood organisational, interpersonal, and time management skillsEnthusiastic, flexible, conscientious and proactive in approachTakes a positive approach to own training and developmentWillingness to learnBenefits:Company eventsCycle to work schemeFree parkingHealth & wellbeing programmeLife insuranceOn-site parkingPrivate medical insurance