Microbiology, GMP, QA, GC, FDA, EMA, Written & Oral Communication Skills,
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Start Date: 1st of April
Work type: On site
Duration: 8 months
- Ensure facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participate in developing action plans
- Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions.
- Collaborate with cross-functional teams to ensure contamination prevention and control requirements are met for new product introductions, facility adaptations, and process
- Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures
- Provide microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control
- Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, and hygiene best practices
- Supports regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert
- Bachelor's degree in a relevant scientific discipline (preferably in microbiology)
- GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
- Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
- Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control
- Excellent written and oral communication to include accurate and legible documentation skills
- Strong sense of ownership and the ability to prioritize based on business needs is necessary
- Fluency in English, ability to communicate in or willing to learn German
What’s an offer?
You get to work in a dynamic environment in a company that really values it’s employees.
Apply now by submitting your resume here or sending it directly to email@example.com