Marketplace Technical

Sterility Assurance Officer

Location
England, Hertfordshire, Borehamwood
Salary
Negotiable
Posted
08 Jun 2021
Closes
06 Jul 2021
Ref
MATECBB424SAO12
Contact
Andrew Williams
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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)

Apply for Sterility Assurance Officer

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

All questions are required

GMP experienced

Microbiology

Sterility


Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs