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:
* 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
* 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 HPLCGC / GCMSUV / IRWet 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 transferTest method development
* 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.
If you would like to apply for this role, please send us your updated CV and cover letter to [email protected]. 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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