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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Location:Bengaluru Area, India Qualification: B. Pharma / M. Pharmacy / M.Sc., 2 - 10 years of Experience in BA BE centre (CRO)/ pharma is preferred.1. To oversee that the quality system is established and effectively implemented as per the requirements of DCGI, NPRA, ANVISA, ISO 15189: 2012 and NABL, head the QA Department. 2. Regulatory Audit clearance like DCGI / other regulatory authority and collecting, updating and communicating with various local and international regulations and guidelines, important information among various departments 3. Reviewing all the study related documents for Ethic Committee Submission as well as Study Reports / Study Dossier of all the trial before submitting to the sponsor for each trial independently. 4.Tracking and archival of SOPs, their distribution, monitoring and control. 5. Performing Quality Control review of documents, case report forms, protocols, informed consents, policies, procedures and reports of undertaken clinical studies. 6. Evaluating and taking corrective actions on deficit areas on the basis of feedback. 7. Performing Internal Audit on site- specific files, master files and various others as per the local and international guidelines and regulatory requirements. 8. Participating, developing and implementing a comprehensive and standardized Quality Management Plan for the organization. 9. Reviewing all the study related documents for Ethic Committee Submission as well as Study Reports / Study Dossier of all the trial before submitting to the sponsor for each trial independently.,
Keyskills :
iso feasibilitystudies graphicdesign hydraulics newproductdevelopment musicmaking ts internalaudit qualitysystem qualitycontrol qualitymanagement aserep tf ms studyrep rectiveactions internation