Description
For one of our clients in the pharmaceutical industry, we are currently looking for a GMP COMPLIANCE - Sterility Support
Start: ASAP
Duration: Min 6 months+ extension
Location: South of Brussels
FUNCTION DESCRIPTION:
GMP Compliance Expert - Sterility Assurance
KEY RESPONSIBILITIES:
- Sterility Assurance Quality Oversight
- Shop floor verification of commitment implementation (access to classified production areas)
- Direct interaction with production staff to ensure proper compliance alignment.
PREREQUISITES:
Education:
- University degree in a relevant scientific domain
Knowledge:
- International GMP
- Aseptic processes and ways of working: hands on practical experience
- Production experience in aseptic environment (primary and/orsecondary production process)
- Aseptic technology: Complete knowledge of LAF, RABS and Isolatorsprinciples, limitations and controls.
- Environmental Monitoring Program: program design, implementation,validation and related deviation/investigation
- Media Simulation: conception, design and execution
- Continuity Grade A principles; disinfection, material transfert andassociated risk mitigation
- FDA Inspections
- Quality systems
Experience:
- 15 years Pharmaceutical/Biotech Industry
- Work in a complex origanisation
- Coaching or mentoring role in GMP environment
- Experience in a post warning letter or consent decree (is a plus)
Language requirement: French (manfatory)/English