Job Description:
Should have exposure to USFDA Audit
Perform routine microbiological sterility, bioburden verification testing on drug substances and Drug Products and water testing in accordance with Specs/STPs and Standard Operation Procedures (SOP) for product release.
Maintain the Microbiology for reconciliation of Media and media plates.
Perform the Microbiology Method validation/Verification and suitability studies of Methods.
Ensure the completeness of Laboratory log-books and associated records, preparation of test solutions and all the data generated during the analysis including review of the analytical results.
Ensure compliance with the good laboratory practice and safety regulations within the laboratory.
Perform the Microbiology equipment qualifications and maintenance.
Immediately / Proactively inform to management of critical deficiencies (OOS/OOTs/Incident/Deviations) and/or departure from SOPs/ policies discovered at any point.
Coordinates for the timely reporting, analysis, investigations and resolution of non-conformances/complaints.
Apply Here
Should have exposure to USFDA Audit
Perform routine microbiological sterility, bioburden verification testing on drug substances and Drug Products and water testing in accordance with Specs/STPs and Standard Operation Procedures (SOP) for product release.
Maintain the Microbiology for reconciliation of Media and media plates.
Perform the Microbiology Method validation/Verification and suitability studies of Methods.
Ensure the completeness of Laboratory log-books and associated records, preparation of test solutions and all the data generated during the analysis including review of the analytical results.
Ensure compliance with the good laboratory practice and safety regulations within the laboratory.
Perform the Microbiology equipment qualifications and maintenance.
Immediately / Proactively inform to management of critical deficiencies (OOS/OOTs/Incident/Deviations) and/or departure from SOPs/ policies discovered at any point.
Coordinates for the timely reporting, analysis, investigations and resolution of non-conformances/complaints.
Apply Here
