Quality Assurance Specialist
Current- Implement and maintain quality systems to comply with GMP, GLP, and regulatory guidelines such as FDA, EMA, and ICH.- Conduct internal and customer audits.- Ensure compliance with internal and external regulations.- Identify risks/deviations, conducting root cause analysis, and implementing CAPA to improve quality system.- Customer Management: Collaborating closely with customer to understand their quality requirements and ensuring effective communication throughout the project lifecycle. - Managing multiple projects simultaneously, including coordinating timelines, resources, and deliverables to meet customer expectations and project deadlines.- Providing training on quality systems/procedures, staying updated on industry trends/regulatory changes, and driving continuous compliance and process improvement.
