QA Compliance Microbiologist

Job ref: QACM100425 Job type: Permanent Location: Newry Closing date: Thursday 24 Apr 2025 17:00 We are recruiting fo a QA Compliance Microbiologist within the QA Cleanroom Compliance department. You will provide quality oversight to ensure adherence to all aspects of cleanroom behaviours, gowning, aseptic technique, cleaning & disinfection, transfer procedures and facility standards for classified cleanrooms in line with regulatory requirements. This role will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms. Main Activities/Tasks Work closely with cleanroom team to ensure alignment with best aseptic practices, standard operating procedures and GMP requirements. Participating in regular cleanroom inspections to promote continuous improvement and compliance. Quickly identifying and documenting all deficiencies found during cleanroom inspections and support with assessing risk to product. Initiating and supporting remediation measures and investigations required in response to the cleanroom inspections finding and environmental monitoring trends. Arrange & deliver initial training for personnel working in the classified cleanroom environment. Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends. Assisting in the reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements. Support with the selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments, stationary. Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment. Support simplification & efficiency initiatives. Participate in customer and regulatory audits. Be flexible to take any other duties as required by Management. Essential Criteria: Educated to at least Degree level or equivalent in a biological science or engineering field or have minimum 2 years' experience within a high-grade cleanroom environment. Excellent attention to detail and highly organised. Strong computer skills and proficient in the use of Microsoft Office with the ability to generate reports. Flexibility to work a shift pattern which may incorporate nights and/or weekends. Excellent oral and written communication skills. Desirable Criteria: Practical experience of good aseptic technique in a manufacturing cleanroom. Minimum of 1 years' experience in a training role. Prior experience of troubleshooting, performing investigations and preparing for regulatory inspections / customer audits. Good knowledge of cleanroom design; current good manufacturing practice; environmental monitoring requirements for aseptic processing facilities. Prior auditing experience. Additional Information: This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy. Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. We regret that applications received after the closing date and time will not be accepted. We are unable to sponsor or take over Visa sponsorship at this time. Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community. To Apply Please forward your CV via the APPLY Now button below.

Location: Newry, GB

Posted Date: 4/19/2025