QA Associate GMP
Good understanding of FDA and EMA regulations and guidelines Why Choose R&D Partners? As an employee, you have access...
Good understanding of FDA and EMA regulations and guidelines Why Choose R&D Partners? As an employee, you have access...
and EMA requirements. Collaborate with laboratory staff, Quality Assurance, validation, facilities, and vendors to resolve...
qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA...
of FDA and EMA regulations and guidelines Excellent organizational, communication, and interpersonal skills. Preferred...
Good understanding of FDA and EMA regulations and guidelines Why Choose R&D Partners? As an employee, you have access...
with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA Experience in interacting...
understanding of Computerized System Validation (CSV) principles and lifecycle management In-depth knowledge of FDA, EMA, GxP...
. Additional Skills & Qualifications Experience supporting global regulatory submissions (FDA, EMA). Knowledge of child-resistant...
authorities, including FDA, EMA, Health Canada, MHRA, and other global agencies. Serve as a subject matter expert in Veeva RIM..., BLA/NDA, MAA). Strong knowledge of global regulatory requirements (FDA, EMA, ICH). Proven experience working in a fast...
Certification Leadership experience Additional Skills & Qualifications Dermatology experience EMA experience Work Environment...