Quality Analyst - QC Aerosols

Job Description

Job Title: AerosolsQuality AnalystLocation - Holmes Chapel (travel to site is required)5 Days on-site and 2 days off, with the 6-2 or 2-10 shift patter (15% bonus is granted for working the shift pattern which bumps the hourly rate) Base rate - £13.68 with shift premium of £15.73 per hourContract until 30th September 2023JOB PURPOSEThis 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 aredelivered at all times.Quality Analysts within Quality Control conducts testing, reporting and investigating of analytical samples for the specific laboratory area (Incoming Goods, In-Process, Finished Product). The Quality Analyst is charged with performing their work ina safe and effective manner in compliance with cGMPand Regulatory requirements. The function of this position is to perform chemical testing following approved methodology, to assure that the potency, purity, safety and stability of our products, components and in-process stages are in compliance withapproved specifications. Additionally, this position evaluates analytical methods, reviews test results, highlights problems related to technicaland equipment issues and works closely with the Senior Quality Analyst/Analytical Quality Leader to aid resolution of any issues. All staff may be required to perform additional duties as agreed by the supervisor.This role uses and builds on their broad knowledge and experience tocoach & trainproblem solvinglead improvement & manage changeKEY RESULTS/ACCOUNTABILITIESDelegate/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.Coach & trainMay have involvement in the training of other members within the team, particularly in the case ofteam members who are new and inexperienced.Problem solveHas regular involvement with investigations (i.e. Events/ILI/FSI), working within their local area toaid 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 considerationsRequirements of the jobMaintains relationships within team as well as with various customer groups, and cross functional teams. Expected to maintain relationships with other process ownersPromotes a culture of trust and openness in which colleagues are encouraged to openly contributeInteracts with personnel within the team on compliance matters.Scope/ImpactSupports meeting local and functional, objectives.Supports the completion of milestones for specific projects.SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

• 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, communicationat 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 performanceTakes 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, Pharmacopeial 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.

If you feel you would be a good fit for the role of QA, please apply with your most up to date CV