, Implement and maintain the systems to ensure its reliable operation status and compliance with regulatory requirements (FDA, EMA...
comply with cGMP, FDA, EMA, and internal quality system requirements. Support training documentation, qualification records...
. RESPONSIBILITIES: Execute cGMP batch manufacturing processes in cleanroom environments. Ensure regulatory compliance (FDA, EMA... experience relevant to the position Strong understanding of cGMP, GDP, and regulatory standards (FDA, EMA, etc.). Experience...
) Identify risks and mitigation strategies, ensuring compliance with industry regulations (e.g., GxP, FDA, EMA). Mentor junior...
with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. Lead and implement Computerized System...
interpreting for FDA, PMDA, or other international regulatory agency inspections (e.g., ANVISA, MHRA, EMA). Familiarity...
and/or products are introduced. Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety...
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...
high-level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the...