Microbiology Assurance Officer

£20,000 - £24,999
Sep 17, 2017
Oct 20, 2017
Contract Type
Full Time
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. The role: • 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