Description
We are looking for a
Sterile Subject Matter Expert - QA Manager (Environmental Control) (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in Lower Saxony
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Environmental control which includes creation of procedures for cleaning and disinfection of rooms and equipment
- Validation of cleaning and disinfection agents
- Creation of environmental monitoring plan for PQ and routine
- EM sample management
- Smoke studies
Your qualifications
- BS in Microbiology, Biology, Pharmacy or other related sciences
- Significant experience in human health sterile manufacturing and/or sterile compliance (subject matter expert)
- Experience in a FDA regulated environment
- Proven ability to author GMP documentation
- Excellent teamwork skills as well as communication and training skills
- Project experience and ability to work independently
- Ability to operate in a global environment with a high level of diversity and various cultures
- Fluency in German and English
Skills:
- Quality manager
Keywords: Qualitätsmanager