Marketplace Technical

Sterility Assurance Officer

England, Hertfordshire, Borehamwood
08 Jun 2021
06 Jul 2021
Andrew Williams
Quality, QA / QC
Full Time
Contract Type
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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