Microbiology Assurance Officer

Posted 17 September by Marketplace Group

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.

Reference: 33328389

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