As the "Quality Assurance (QA) GCP Manager“ within the GCP and GVP Quality Department, you will play a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Clinical Practice (GCP) guidelines. * Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines * Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external) * Create and regularly update quality standard operating procedures (SOPs), policies, and checklists to ensure compliance with current GCP standards * Develop and implement targeted training programs on GCP and quality assurance principles to ensure proficiency and compliance * A minimum of 4-5 years of experience in GCP quality assurance or related fields within the ...
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