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Sterility Assurance Officer

Zoek Pin Borehamwood, Hertfordshire, England

Permanent (Full time)

Posted 4 days ago

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 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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