Consultant (m / w / d) Life Science Compliance

• Equipment qualifications, commissioning, and method validations
• Preparation of qualification and validation plans for laboratory and production-related processes
• Preparation and review of specifications and risk analyses
• Planning and execution of IQ-OQ-PQ
• Processing of changes and deviations
• Creation of Standard Operating Procedures (SOPs)
• Maintenance and archiving of documents
• Provide training and ensure training standards
• Support of pharmaceutical release laboratories in GMP activities
• Active support in the business development

Your profile

• BS degree in either pharmaceutical sciences, biotechnology, engineering, or chemistry
• Practical experience in a pharmaceutical laboratory or production environment
• Practical experience in quality Management
• Very good GMP knowledge and in-depth knowledge of other regulatory requirements
• Professional experience in the qualification of laboratory equipment & facilities
• Experience in method validation of analytical methods
• Experience in LIMS or MES environment is an advantage
• Careful, self-contained, and responsible way of working
• Excellent verbal & written communication in German and English as well as strong experience in working with computer systems
• High degree of quality awareness, strong communication skills, and the ability to work in interdisciplinary teams
• Willingness to travel