Biologe (m/w/d)
Core
Quality Assurance Specialist supporting preclinical development projects in Pharma, Biotechnology, Chemistry, and MedTech by ensuring compliance with GLP and GMP standards.
Role type
Quality Assurance Specialist
Builds
compliant documentation, SOPs, and validated processes for client projects
Domain
Life Sciences / Regulatory Compliance
Required skills
GLP/GMP knowledge, audit planning and coordination, SOP creation and maintenance, supplier qualification, regulatory communication, training and mentoring
Preferred skills
Life Sciences background, Quality Management experience
Technologies
GLP, GMP, SOPs
Responsibilities
Review and evaluate study documentation and data for GLP/GMP compliance; Create, review, and maintain Standard Operating Procedures (SOPs); Plan, coordinate, and support internal and external audits and inspections; Organize and oversee qualification and validation measures; Support quality-related communication with clients, auditors, and authorities; Conduct supplier and service provider qualifications; Train colleagues on quality-related topics
Seniority
Entry to Mid-level, hands-on IC
