QC Microbiology Manager managing microbiological activities in Dessau at Merz Aesthetics. Responsible for environmental monitoring and compliance with QC activities.
Responsibilities
Responsible for the strategic leadership and management of microbiological activities in Dessau
Environmental monitoring and outsourced microbiological product testing
Internalization of microbiological testing
Responsible for the day-to-day operations of microbiological activities and compliance with QC activities
Lead the microbiology department to establish a QC laboratory
Develop, improve and maintain microbiological testing methods
Identify and oversee initiatives for operational excellence in microbiological test procedures
Lead product testing, environmental monitoring and water testing
Manage external providers for microbiological testing
Ensure a safe working environment in the laboratory.
Requirements
BS/BA in a natural science or related field
B.S. degree in Microbiology
GLP/GMP experience required
Minimum 5 years of experience in a pharmaceutical or medical device laboratory
Professional experience leading a microbiology laboratory in the pharmaceutical or related industry
In-depth knowledge of microbiology
Experience applying various microbiological techniques for product testing (bioburden, endotoxin and sterility testing) and for environmental monitoring (water, air and surface monitoring)
Strong technical knowledge in a GMP environment
Solid knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/820 and EU GMP Annex 1, relevant USP/EP methods, ICH, ISO 14644, ISO 14698, GLP
Experience with laboratory equipment IQ/OQ/PQ
Fluent English, written and spoken
MS Office products (Word, Excel, Outlook, PowerPoint)
Proficiency in word processing, spreadsheets, databases and statistical analysis
Preparation of test protocols and reports, operational documentation and procedures.
Benefits
People first: An open working culture with flat hierarchies and short decision-making paths.
Family & work: Company-run childcare at our locations.
Balanced work-life harmony: Flexible working models, flexitime and trust-based working hours.
Professional development: Regular development talks and a wide range of management and technical training.
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