Key Responsibilities

• Lead the setup, implementation, and day-to-day operation of a GMP-compliant microbiology laboratory
• Oversee microbiological testing activities, including bioburden, sterility, endotoxin testing, microbial identification, environmental monitoring, and water testing
• Define and maintain microbiology standards to ensure compliance with EU GMP, FDA.
• Develop, implement, and maintain the laboratory Quality Management System (QMS), including SOPs, test methods and policies.
• Design, implement, and maintain environmental monitoring programmes, including sampling plans
• Environmental Monitoring Data Management include charting, analyzing data, interpreting the overall monitoring process behavior, detecting a trend or shift in contamination levels, monitoring excursion rates. 
• Participate in the development of the Contamination Control Strategies
• training staff in aseptic manufacturing process to address regulations to prevent microbiological contamination of the pharmaceutical product.
• Collaborate with cross-functional teams to ensure an effective cleaning validation program and participate in disinfection programs development.  
• Ensure laboratory audit readiness and support internal, client, and regulatory inspections.
• Lead and support deviations, investigations, and non-conformances

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related field. Master's degree is a plus.
• Proven experience in a laboratory leadership or management role
• Strong knowledge of GMP standards and expertise in microbial identification, testing techniques, and laboratory instrumentation.
• Strong knowledge of Risk-based approaches through the subsequent ICHQ9 guideline on risk management for the manufacture of sterile pharmaceutical products.
• Excellent problem-solving skills with strong attention to detail
• Strong communication skills, both written and verbal, in Greek and English