Laboratory Analyst

3 weeks ago

Derby Derbyshire, United Kingdom Tentamus Group GmbH Full time

The function of the department is to analyse sterile and non-sterile products and materials to determine quality. This position will provide basic technical tasks as required under supervision to the laboratory facility.

Objectives / Purpose: The Laboratory Analyst should perform laboratory analysis and:
  • Be aware of the safety implication of operations within working environment ensuring compliance with working practices and procedures
  • Be aware of regulatory requirements ensuring compliance with working practices and procedures
  • Co-operate as necessary with the audit team(s) to ensure that the audit process is effective, efficient and achieves its objectives
  • Comply with all procedures of the QMS
  • Following Department Schedule plans, organise own work as required ensuring that all objectives and deadlines are met
  • Complete documentation as directed by procedure and in compliance with Good Document Practice and GMP
  • Identify and assess faults/process failure and report complex faults and appropriate remedial action
Principal roles and responsibilities: Safety:
  • Safety procedures always followed
  • Correct use of PPE
Documentation:
  • Full, neat, accurate, and completion of documentation in a timely manner
  • Prompt and correct reporting of deviations from SOP
  • Good housekeeping and cleanliness
  • All documentation recorded contemporaneously in compliance with Data Integrity
Quality Assurance:
  • Provide appropriate information in a timely manner
  • Maintain the laboratory area in an audit ready condition
  • Comply with SOPs
  • Discrepancies always raised
Laboratory Analysis:
  • Instructions followed precisely and outcome reported
  • Agreed deadlines met
  • Identify and report when objective is not feasible
  • Report all failures in a timely manner
  • Report all remedial action
  • Perform routine laboratory analysis in accordance with current BP/EP/USP and client methods
    • HPLC
    • GC / GCMS
    • UV / IR
    • Wet chemistry (limit tests, identification tests, titration, reaction chemistry)
    • Solid dosage form (dissolution, disintegration, hardness, friability)
    • Autotitration techniques
  • Perform non-standard laboratory analysis as required
    • Test method validation (ICH/VICH)
    • Technology transfer
    • Test method development
  • Be able to provide input to Investigations of OOT / OOS results
  • Repot analysis results
  • Check analysis results as required
  • Perform basic maintenance and repair of laboratory equipment
  • Maintain laboratory instrument log books
  • Write and review SOP as required
  • Perform daily and weekly housekeeping activities

This position is applicable to workplace entry-level graduates, or those with lower educational qualifications with prior laboratory experience of at least 2 years.

If you would like to apply for this role, please send us your updated CV and cover letter to ApplicationsUK@tentamus.com .

Please, include the job position in the subject of your email in the following format TPUK: Lab Analyst .

We look forward to receiving your application

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