Systems. Experience in a 503B Compounding manufacturing environment. Experience in FDA/EMA regulations in biopharmaceuticals...
with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. Lead and implement Computerized System...
compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. Conducting risk assessments...
and/or products are introduced. Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety...
approved Standard Operating Procedure Manual, EMA, OSHA, CLIA, cGMP, as well as all internal company procedures, in process... fashion. Maintain a familiarity of State and Federal Regulations, FDA approved Standard Operating Procedure Manual, EMA, OSHA...
efficient resource allocation Quality & Regulatory Compliance: Ensure adherence to cGMP, ICH GCP, FDA, EMA guidelines;manage... and quality management Strong understanding of cGMP regulations, quality systems, and global regulatory expectations (FDA, EMA...
) Identify risks and mitigation strategies, ensuring compliance with industry regulations (e.g., GxP, FDA, EMA). Mentor junior...
interpreting for FDA, PMDA, or other international regulatory agency inspections (e.g., ANVISA, MHRA, EMA). Familiarity...
expansion. Ensure alignment with cGMP, ISO 14644, FDA, EMA, ISPE, PDA, and GLP requirements. Participate in GMP reviews, risk...
, Implement and maintain the systems to ensure its reliable operation status and compliance with regulatory requirements (FDA, EMA...