Quality Analyst - Holmes Chapel, UK Holmes Chapel, England
Job description
Competitive salary and bonus + excellent benefits
Days shift
Holmes Chapel, UK based
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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
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§ Good 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 PowerPoint
§ Demonstrated ability to actively participate in projects and investigation
§ Knowledge 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 meeting
§ Good interpersonal skills with an ability to communicate procedures and concepts within the team and on occasions to the department. Ability to train instructional techniques
§ Self-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 performance
§ Takes responsibility for supporting change, is prepared to take or support action, and/or escalate to ensure implementation of appropriate actions
§ Ability to respond to auditor questions and describing local systems on external audit tours with positive outcomes
§ The individual should have good knowledge and understanding of the principles and concepts of compliance management and GMP/GLP
§ The 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.
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§ A science degree / HND/ NVQ 4 or equivalent with at least 1 years working experience in a GMP environment
