Primary Function Provide technical and professional expertise to the QC microbiological laboratory, supporting manufacturing / customer supply, quality and regulatory aspects of the business. Primary Accountabilities/Responsibilities
Lead analytical investigations within the QC micro lab, ensuring that customer supply and quality is maintained at all times.
Perform routine analytical testing and/or Second Person data verification (2PV) and/or Test Result Release (TRR) if required by the business.
Oversight of method validation and routine testing of products and excipients in accordance with USP/EP requirements. In particular, microbial enumeration and absence of specified microorganism testing in accordance with EP chapter 2.6.12 & 2.6.13 and USP chapters <61> and <62>.
Oversight of the microbiological testing of purified water plus other water grades.
Experience in the identification of microorganisms, media preparation (including growth promotion testing), microbial culture preparation and maintenance and the use of autoclaves.
Understanding of potentially objectionable microorganisms and ability to generate microbiological risk assessments as required.
Oversight of the environmental monitoring program including viable (microbial) and non-viable (particulate) monitoring and responding to environmental monitoring excursions.
Responsibility for performing an annual review of the environmental monitoring data and implementation of alert & action limits as well as assessment of the normal microbial flora of the area
Assist quality leadership team in attaining a culture of world-class customer service, world-class quality, continuous improvement and a commitment to excellence within the department, the site and the company.
University degree in Microbiology
At least 10 years of experience in execution of microbiological testing in pharmaceutical field.