The function of the department is to analyse sterile and non-sterile products and materials to determine quality. This position works with supervision and will provide basic technical tasks as required to the laboratory facility in Microbiology Departments.
Objectives
* Perform microbiological analysis and be aware of the safety implications of operations within the 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.
* Complete documentation as directed by procedure.
* Report faults/process failure and report complex faults or take appropriate remedial action.
Roles and Responsibilities:
Safety:
* Always follow safety procedures.
* Correct use of PPE.
Documentation:
* Full, neat, accurate, and timely completion of documentation.
* Prompt and correct reporting of deviations from SOP.
* Good housekeeping and cleanliness.
Quality Assurance:
* Maintain the laboratory in an audit-ready condition.
* Provide appropriate information in a timely manner.
* Comply with SOPs.
* Discrepancies always raised.
Laboratory Analysis:
* Follow instructions precisely and report outcomes.
* Identify and report when objectives are not feasible.
* Report all failures in a timely manner.
* Report all remedial actions.
* Perform routine microbiological analysis in accordance with current BP/EP/USP and client test methods.
* Order laboratory consumables to ensure a ready supply above minimum stock levels.
* Perform routine microbiology laboratory analysis of a range of pharmaceutical forms.
* Microbial Limit Testing according to current EP/USP requirements.
* Sterility testing.
* Organism identification by gram stain and Vitek2.
* Antibiotic assay.
* Bacterial endotoxin testing using turbidimetric method.
* Water testing.
* Media preparation.
* Preservative efficacy testing of pharmaceutical products.
* Perform non-standard laboratory analysis as required: Environmental monitoring.
Disinfectant Challenge Testing using BSEN Test Methods:
* Investigation of OOT/OOS results.
* Achieve the level of accuracy required.
* Report analysis results.
* Maintain laboratory equipment log books.
* Perform daily and weekly housekeeping activities.
If you would like to apply for this role, please send us your updated CV to [emailprotected].
Please, include the job position in the subject of your email in the following format: TPUK: Microbiologist.
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