Quality Analyst

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Quality AnalystHolmes Chapel6 month contract with view to extend£11.24 - £13.03 p/h PAYE This role provides testing, reporting and investigation laboratory activities to enable compliant, on time delivery of product to market. This is a key position within a QC team ensuring that the exacting standards of GMP, Site procedures, HSE and LEAN are delivered at all times. Key Accountabilities:Delegate/allocate work and monitor performanceConducts testing of QC samples for the specific laboratory area and manage own workloadAnalyse data using standard proceduresContribute to quality key performance indicators and deliver, measure/trend data to team. Challenge and seek improvements in ways of working/processesPerform testing according to prioritisation and contribute to any improvementsProvide analytical /lab support for Team Leader in internal, Global regulatory inspections and customer audits when required.Problem solveHas regular involvement with investigations (i.e. Events/ILI/FSI), working within their local area to aid in problem solving, identification of root cause and meaningful CAPA. Lead improvements & manage changeRecognises opportunities for change and has a proven ability to drive change in the local area.May be required to support in the review of analytical methods and compendia to ensure compliance for both GMP and HSE considerations QualificationsA science degree / HND/ NVQ 4 or equivalent with at least 1 years working experience in a GMP environment SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTSGood technical knowledge and expertise of quality control principles and systems in a GMP environment.Computer-literate with experience in the use of Laboratory (LIMS, Data capture) systems as well as MS Word, Excel and PowerPointDemonstrated ability to actively participate in projects and investigationKnowledge and understanding of global pharmaceutical regulations and guidelines.Demonstrates competence and clarity in both written and oral communication e.g. presentations at team meetings, ability to write ILIs and demonstrates understanding to execute FSIs as well as non-complex technical and investigational reports, communication at team meetingGood interpersonal skills with an ability to communicate procedures and concepts within the team and on occasions to the department. Ability to train instructional techniquesSelf-motivated with ability to plan and manage own workload with some supervision during the working day.Challenges and questions locally and across team ways of working to seek improved processes and performanceTakes responsibility for supporting change, is prepared to take or support action, and/or escalate to ensure implementation of appropriate actionsAbility to respond to auditor questions and describing local systems on external audit tours with positive outcomesThe individual should have good knowledge and understanding of the principles and concepts of compliance management and GMP/GLPThe individual should have a good understanding of analytical chemistry or microbiology, laboratory instrumentation and/or related information systems.The individual should have a basic understanding of the industry and be responsive to of regulatory changes, new technologies, Pharmacopoeial requirements and their impact on the function.An understanding of own quality assurance function, as well as a basic understanding of other functions and how they contribute to achieving the objectives of the business.The individual has some understanding of business functions and supports reacting to issues on how QC performance impacts functional customer service.