We are currently looking for a Sterility Assurance Officer to join a leading biopharmaceutical company based in the Hertfordshire area. As the Sterility Assurance Officer you will be 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, the review of data; generating data review reports, and for producing risk assessments. Occasional sample taking and visits to process areas, including aseptic processing facilities is required.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Sterility Assurance Officer will be varied however the key duties and responsibilities are as follows:
1. Quality assurance function for contamination, including record review and offering advice to manufacturing.
2. 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. Including proposing appropriate corrective and preventative actions.
3. To undertake microbiological sampling and testing as required in relating to such areas as environmental monitoring and water systems.
4. To support production and technical divisions including formulating and inputting into other risk assessments as required.
To be successful in your application to this exciting opportunity as the Sterility Assurance Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in microbiology or relevant Bioscience
2. Minimum 2 years' experience in pharmaceutical sector, working in a pharmaceutical microbiology function.
3. Prior training in continuous improvement or risk assessment methods