Apply to JobJob ID224894BRPosition TitleSenior Process Expert MicrobiologySourcing Statement You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.Job DescriptionKnowledge management:
• Owns the knowledge of sterile pharmaceutical manufacturing processes with focus of aseptic manufacturing in conventional filling lines and in isolator filling lines from a microbiological and process-technological point of view
Subject Matter Expert SME for Media Fills:
• Deep Subject Matter Expertise for Media Fills for the validation of aseptic processes for sterile drug products (mainly biologics)
• Designs and controls optimization and implementation projects relevant to his/her specific expertise
• Supports Process Experts and Quality Assurance and Product Stewards in defining, harmonizing and optimizing all aspects related to Media Fills across the units
• Collects and documents all Media Fill related information in order to have them available for regular trending, annual planning of media fills and summarizing media fills in yearly reports
• Provides overview of all Media Fill related strategical changes, local changes and deviations
• Acting as SPOC for registration dossiers related to Media Fill and for Health Authorities questions
• Being the owner of all relevant Media Fill SOPs and support the establishment of Media Fill Master Batch Records
Support for additional microbiological related topics:
• Support further microbiological related topics/project within the scope of MS&T (Manufacturing, Science & Technology)
Audit support:
• Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentationMinimum requirements• BSc. or MSc. (desirable) in Pharmacy, Pharmaceutical Technology, Microbiologists or equivalent scientific degree
