International Pharmaceutical Manufacturer requires a Microbiology Compliance Officer to take responsibility for the 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.
- 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 detailed reports into investigation findings.This includes 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, databased and LIMS.
- To undertake risk reviews of pharmaceutical processing areas, including aseptic filling areas.
- To undertake microbiological sampling and testing as required in relation 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 SOPs as required.
- 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.
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job