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Quality Compliance Specialist
beBeeQualityHyderabad, Telangana, India20 days ago
Job descriptionBachelor's degree in a relevant field or equivalent experience in quality assurance. Strong analytical skills to identify discrepancies and draw logical conclusions from audit findings. Attention to detail when reviewing documents, data, and processes. Excellent written and verbal communication skills to effectively convey audit results. Thorough understanding of GCP, International Conference on Harmonisation (ICH) guidelines, and other clinical trial regulations.
As a dedicated Quality Assurance professional, you will play a pivotal role in ensuring the integrity of our clinical trials. Your expertise will be instrumental in maintaining compliance with regulatory standards and quality guidelines.
Key Responsibilities :
- Conduct thorough audits to verify adherence to Good Clinical Practice (GCP) guidelines, company Standard Operating Procedures (SOPs), and other pertinent regulations.
- Analyze quality management systems, identifying root causes of events, incidents, and complaints to recommend corrective actions.
- Prepare detailed audit reports, documenting findings, non-conformities, and suggestions for improvement.
- Stay up-to-date with evolving regulatory requirements, communicating and implementing changes across the organization.
Required Skills and Qualifications :
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Compliance Specialist • Hyderabad, Telangana, India