This is a Microbiologist Specialist role. The candidate will come and support some of their projects to help push through Microbiology SOPs, documents related to testing, etc. They will NOT be doing routine testing. but rather focusing on method validation and and report writing (investigations, writing final reports etc.). Must have experience with USP (6171 and 85). The candidate will:-Plan, coordinate and organize the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.-Directly responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS result.-Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.-Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.-Prepares trend analysis and data compilation on deviation in the production process when required.-Supports microbiological tasks for process validation.Skills:
Microbiology, method validation, gdp, GmpTop Skills Details:
Microbiology,method validation,gdpAdditional Skills & Qualifications:
Bachelors Degree: Microbiology, Biology or scientific Industry1-3 years of USP experience1-3 years in Method validation in microbiologyExperience Level:
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