Clinical Quality Manager
Clinasia Labs Private Limited - Hyderabad, Andhra Pradesh
Clinasia Labs Private Limited - Hyderabad, Andhra Pradesh
Good experience in CDISC, SDTM, GCP, ICH, FDA, 21 CFR Part 11 and other regulatory requirements/ Standards Review and audit clinical/PV/non-clinical documents, Review audit the Protocols, CRFs, Clinical Study Reports, Monitoring Visit Reports, Mock (TLFs) and other study related documents, data conversion deliverables based on CDISC, SDTM ADaM etc. Perform Internal Process audits and gap assessments Should have experience in creating, review approval for the SOPs, Policies, Work Instructions, Guidelines etc. for Clinical Research services Proactive and polished communication skills, verbal and written Superb attention to detail internal quality GCP programs in accordance with company and industry quality principles and regulations Provide GCP expertise to the organization through in depth current knowledge of regulatory requirements and company quality standards Maintain contemporary knowledge of changes in regulations and enforcement action and make recommendations for changes to policies and practices as needed Experience in quality assurance, clinical development, Software validation, field monitoring or auditing is a plus. Experience in Implementation and monitoring of ISO certifications e.g. ISO 9001 (Must to have), 27001, 20000 is an added advantage Review and Approve of Change Controls, Deviation Control and actively participate and providing guidance in each step of investigation to identify the root cause and defining appropriate CAPAs considering the previous occurrence. Conducting cGCP applicable Trainings periodically for all employees. |
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