Sterility Assurance Officer
- Experience Level
- Experienced (non-manager)
International Pharmaceutical Manufacturer seeks an experienced Sterility Assurance Officer.
About the role:
A Sterility Assurance Officer is responsible for the quality assurance of process environments in relation to microbial contamination. The officer is responsible for investigation of microbiological out-of-limits samples; for the review of data; for generating data review reports; and for producing risk assessments. Occasional sample taking and visits to process areas, including aseptic processing facilities is required.
Duties may include:
- Quality assurance function for contamination, including record review and offering advice to manufacturing.
- To be knowledgeable of pharmaceutical microbiology and aseptic processing.
- To investigate microbiological out-of-limits events relating to such areas as bioburden, endotoxin, sterility, water systems and environmental monitoring.
- To write details reports into investigation findings. This including proposing appropriate corrective and preventative actions.
- To conduct or review out-of-specification reports or reviews into invalid tests.
- To produce data trend reports in graphical and statistical formats.
- To use risk assessment tools and to produce risk assessment reports.
- To input and export data through the use of spreadsheets, databases and LIMS.
- To undertake risk reviews of pharmaceutical processing areas, including aseptic filling areas.
- To undertake microbiological sampling and testing as required in relating to such areas as environmental monitoring and water systems.
- To conduct audits, with a focus on contamination control.
- To conduct equipment and log-book reviews of the Microbiology laboratory.
- To update documents and SOP's as required.
- To attend and contribute to meetings relating to site projects and other BPL quality initiatives.
- To attend and contribute to data review meetings.
- To support production and technical divisions including formulating and inputting into other risk assessments as required.
- To liaise with production staff, to seek process improvements.
Skills and experience:
- Minimum 2 years' experience in pharmaceutical sector, working in a pharmaceutical microbiology function.
- Experience of using graphical tools and understanding basic statistics.
- Experience of aseptic process
- Experience of undertaking auditsCompetent in 50% of testing performed within the department.
- Degree in a relevant scientific discipline and experience working in the pharmaceutical industry (or equivalent)
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