Laboratory Analyst

2 weeks ago

Derby, Derby, United Kingdom Tentamus Full time

Job Summary:

The Laboratory Analyst will be responsible for analyzing 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.

Key Responsibilities:

  • Perform laboratory analysis and ensure compliance with working practices and procedures.
  • Be aware of regulatory requirements and ensure compliance with working practices and procedures.
  • Co-operate 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.
  • Organize 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 will always be followed.
  • Correct use of PPE will be ensured.

Documentation:

  • Full, neat, accurate, and timely completion of documentation will be ensured.
  • Prompt and correct reporting of deviations from SOP will be done.
  • Good housekeeping and cleanliness will be maintained.
  • All documentation will be recorded contemporaneously in compliance with Data Integrity.

Quality Assurance:

  • Appropriate information will be provided in a timely manner.
  • The laboratory area will be maintained in an audit-ready condition.
  • Compliance with SOPs will be ensured.
  • Discrepancies will always be raised.

Laboratory Analysis:

  • Instructions will be followed precisely, and outcomes will be reported.
  • Agreed deadlines will be met.
  • Complex objectives will be identified and reported.
  • 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/MS/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.
  • Be able to provide input to Investigations of OOT/OOS results.
  • Report 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.

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