Sterility Assurance Officer ( Senior Analyst )

International Pharmaceutical Manufacturer seeks an experienced Sterility Assurance Officer (Senior Analyst) on a 12-month FTC.

About the role:

A Sterility Assurance Officer is responsible 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.

Duties may include:

• Notification to next line manager of any deviations or out of specifications/limits/trends identified during normal working practices.
• To deputise for Quality Manager as required.
• Approving of staff to perform activities on successful completion of their training
• 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 attend and contribute to meetings relating to site projects and other 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:

• Experience of working in a laboratory environment
• Understanding of GMP/GLP.
• Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes.
• Knowledge of laboratory SOPs and ability to revise and write new procedures.
• Understanding of knowledge of laboratory operations and practical work.
• Knowledge of stock control and budgeting in own area
• Experience is using analytical equipment and pipettes
• Experience writing reports
• Experience in quality records and investigations
• Experience of audits
• Competent in 50% of testing performed within the department
• Degree in a relevant scientific discipline and experience working in the pharmaceutical industry (or equivalent)