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Micorbiology Expert
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Support
Projektbeschreibung
MICROBIOLOGY EXPERT - 6 MONTHS CONTRACT - SWITZERLAND
WE ARE CURRENTLY LOOKING FOR A MICROBIOLOGY QUALITY ASSURANCE EXPERT TO SUPPORT THE QUALIFICATION AND MANUFACTURE OF DRUG PRODUCTS (SOLIDS)
TASKS: SUPPORT THE MICROBIOLOGICAL QUALIFICATION/VALIDATION OF UTILITIES, CLEAN ROOMS AND EQUIPMENTS. SUPPORT THE SETUP AND LATER THE MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT IN NON-STERILE PRODUCTION FACILITIES (AIR AND SURFACES) INCLUDING DETERGENTS AND DISINFECTANTS IN TIME AND IN ACCORDANCE TO CGMP RULES, QMS AND SOPS.
CORRECT INVESTIGATION AND DOCUMENTATION OF DEVIATIONS AS WELL AS THE TRAINING OF PRODUCTION PERSONNEL WITH REGARD TO HYGIENE. SUPPORT THE "CRITICAL" AND "NON-CRITICAL" MICROBIOLOGICAL DEVIATIONS INVESTIGATION AND APPROVAL OF THE RESPECTIVE MICROBIOLOGICAL RISK ASSESSMENTS. OPTIMIZE THE QUALITY OF THE PROCESSES AND THE MANUFACTURED PRODUCTS AS WELL AS TO MAINTAIN COMPLIANCE WITH AUTHORITY REQUIREMENTS. SUPPORT PREPARATION OF AUTHORITY INSPECTIONS AND PARTICIPATION AS A MICROBIOLOGICAL EXPERT. - SUPPORT AUTHORING AND REVIEWING OF SOPS, EITHER MICROBIOLOGICAL QA/QC-SOPS OR PRODUCTION-SOPS TRAINING OF MICROBIOLOGICAL ANALYST AND PRODUCTION OPERATORS AFTER MICROBIOLOGICAL DEVIATIONS OR AS REGULAR TRAINING. REQUIREMENTS: UNIVERSITY/ACADEMY DEGREE IN GENERAL OR MEDICAL MICROBIOLOGY, BIOCHEMISTRY, PHARMACY OR EQUIVALENT. BIOLOGICAL/MICROBIOLOGICAL ANALYTICS OR DIAGNOSTICS INCLUDING GROWTH PROPERTIES OF MICRO-ORGANISMS AND CULTURE MEDIA PREPARATION; QUALITY CONTROL/ASSURANCE IN PHARMACEUTICAL INDUSTRY OR BIOTECHNOLOGY, ESPECIALLY WITH REGARD TO ENVIRONMENTAL MONITORING AND CLEANLINESS ZONES.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
WE ARE CURRENTLY LOOKING FOR A MICROBIOLOGY QUALITY ASSURANCE EXPERT TO SUPPORT THE QUALIFICATION AND MANUFACTURE OF DRUG PRODUCTS (SOLIDS)
TASKS: SUPPORT THE MICROBIOLOGICAL QUALIFICATION/VALIDATION OF UTILITIES, CLEAN ROOMS AND EQUIPMENTS. SUPPORT THE SETUP AND LATER THE MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT IN NON-STERILE PRODUCTION FACILITIES (AIR AND SURFACES) INCLUDING DETERGENTS AND DISINFECTANTS IN TIME AND IN ACCORDANCE TO CGMP RULES, QMS AND SOPS.
CORRECT INVESTIGATION AND DOCUMENTATION OF DEVIATIONS AS WELL AS THE TRAINING OF PRODUCTION PERSONNEL WITH REGARD TO HYGIENE. SUPPORT THE "CRITICAL" AND "NON-CRITICAL" MICROBIOLOGICAL DEVIATIONS INVESTIGATION AND APPROVAL OF THE RESPECTIVE MICROBIOLOGICAL RISK ASSESSMENTS. OPTIMIZE THE QUALITY OF THE PROCESSES AND THE MANUFACTURED PRODUCTS AS WELL AS TO MAINTAIN COMPLIANCE WITH AUTHORITY REQUIREMENTS. SUPPORT PREPARATION OF AUTHORITY INSPECTIONS AND PARTICIPATION AS A MICROBIOLOGICAL EXPERT. - SUPPORT AUTHORING AND REVIEWING OF SOPS, EITHER MICROBIOLOGICAL QA/QC-SOPS OR PRODUCTION-SOPS TRAINING OF MICROBIOLOGICAL ANALYST AND PRODUCTION OPERATORS AFTER MICROBIOLOGICAL DEVIATIONS OR AS REGULAR TRAINING. REQUIREMENTS: UNIVERSITY/ACADEMY DEGREE IN GENERAL OR MEDICAL MICROBIOLOGY, BIOCHEMISTRY, PHARMACY OR EQUIVALENT. BIOLOGICAL/MICROBIOLOGICAL ANALYTICS OR DIAGNOSTICS INCLUDING GROWTH PROPERTIES OF MICRO-ORGANISMS AND CULTURE MEDIA PREPARATION; QUALITY CONTROL/ASSURANCE IN PHARMACEUTICAL INDUSTRY OR BIOTECHNOLOGY, ESPECIALLY WITH REGARD TO ENVIRONMENTAL MONITORING AND CLEANLINESS ZONES.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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