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Senior QA Specialist, QA Ops Microbiology NOVJP00024196 (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
356837/11
IHRE AUFGABEN:
-As QA-Specialist you are responsible for all relevant microbiological quality assurance aspects of the manufacture and/or release of drug products, starting materials and utilities/water for NTO Solids Stein and NTO Solids Wehr.
-Support microbiological monitoring of the environment in non-sterile production facilities (air and surfaces) including water, detergentsfurthermore, it comprises the correct investigation, QA-decision and documentation of deviations as well as the training of production personnel with regard to hygiene)
-Support qualification/validation of clean rooms and equipment (this activity includes the elaboration of qualification/validation protocols and reports and it comprises trouble shooting and QA-decision in the case of deviations)
-Point of contact for operators, manufacturing personnel, process experts/facilitators, PU Head, TRD, project teams, in terms of general microbiological (GMP-)questions
-Release of drug products, starting materials and utilities/water for NTO Solids Stein, NTO Solids Wehr and ChemOps Production MMZ
-Decision on “critical” and “non-critical” microbiological deviations and approval of the respective microbiological risk assessment
-Ensure correct and timely preparation and dispatch of analysis certificates (CoAs); (in particular, special clarifications in case of problems)
-Participate in the preparation of audits and government inspections (e.g., assisting with the preparation of presentations, trends, evaluations), as well as answering queries and providing information during inspections
-Writing/review/approval of all relevant SOPs
-Providing biological and microbiological services and QA support for global Novartis functions as TechOps and Development
IHRE QUALIFIKATIONEN:
-(Technical) university/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent
-Fluency in German (spoken/written); fluency in English (spoken/written)
-Biological/microbiological analytics or diagnostics experience, 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
WEITERE QUALIFIKATIONEN:
Quality manager
356837/11
IHRE AUFGABEN:
-As QA-Specialist you are responsible for all relevant microbiological quality assurance aspects of the manufacture and/or release of drug products, starting materials and utilities/water for NTO Solids Stein and NTO Solids Wehr.
-Support microbiological monitoring of the environment in non-sterile production facilities (air and surfaces) including water, detergentsfurthermore, it comprises the correct investigation, QA-decision and documentation of deviations as well as the training of production personnel with regard to hygiene)
-Support qualification/validation of clean rooms and equipment (this activity includes the elaboration of qualification/validation protocols and reports and it comprises trouble shooting and QA-decision in the case of deviations)
-Point of contact for operators, manufacturing personnel, process experts/facilitators, PU Head, TRD, project teams, in terms of general microbiological (GMP-)questions
-Release of drug products, starting materials and utilities/water for NTO Solids Stein, NTO Solids Wehr and ChemOps Production MMZ
-Decision on “critical” and “non-critical” microbiological deviations and approval of the respective microbiological risk assessment
-Ensure correct and timely preparation and dispatch of analysis certificates (CoAs); (in particular, special clarifications in case of problems)
-Participate in the preparation of audits and government inspections (e.g., assisting with the preparation of presentations, trends, evaluations), as well as answering queries and providing information during inspections
-Writing/review/approval of all relevant SOPs
-Providing biological and microbiological services and QA support for global Novartis functions as TechOps and Development
IHRE QUALIFIKATIONEN:
-(Technical) university/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent
-Fluency in German (spoken/written); fluency in English (spoken/written)
-Biological/microbiological analytics or diagnostics experience, 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
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges