Quality Analyst

  • Location

    Holmes Chapel, Cheshire

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £20000 - £25000 per annum

  • Contact:

    Experis UK

  • Contact email:

    Gemma.Conreen@experis.co.uk

  • Job ref:

    BBBH128681_1603471408

  • Published:

    about 1 month ago

  • Duration:

    10 months

  • Expiry date:

    2020-12-04

  • Start date:

    ASAP

  • Client:

    #

Quality Analyst

Holmes Chapel

10 month contract

£20,000 - £25,000 per annum pro rata

JOB PURPOSE

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.

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 in a safe and effective manner in compliance with cGMP and 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 with approved specifications. Additionally, this position evaluates analytical methods, reviews test results, highlights problems related to technical and 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.

KEY RESULTS/ACCOUNTABILITIES

  • Conducts testing of QC samples for the specific laboratory area and manage own workload
  • Analyse data using standard procedures
  • Contribute to quality key performance indicators and deliver, measure/trend data to team. Challenge and seek improvements in ways of working/processes
  • Perform testing according to prioritisation and contribute to any improvements
  • Provide analytical /lab support for Team Leader in internal, Global regulatory inspections and customer audits when required.
  • May have involvement in the training of other members within the team, particularly in the case of team members who are new and inexperienced.
  • Has 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.
  • Recognises 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

Requirements of the job

  • Maintains relationships within team as well as with various customer groups, and cross functional teams. Expected to maintain relationships with other process owners
  • Promotes a culture of trust and openness in which colleagues are encouraged to openly contribute
  • Interacts with personnel within the team on compliance matters.
  • Supports meeting local and functional, objectives.
  • Supports the completion of milestones for specific projects.

Qualifications

  • A science degree / HND/ NVQ 4 or equivalent with at least 1 years working experience in a GMP environment

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, 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.