Urgent opening for Clinical QA department.Position :- Officer - Clinical Quality AssuranceExperience :- 2-5 years job location :- Kandivali, Mumbai Qualification :- M pharma , Msc Job description :-1.Performing Vendor Qualification audit and site feasibility audits for Clinical Trial. 2.Preparation of corrective action plans for audit findings in consultation with Clinical Head. 3.Preparation of internal trial master files and site-specific files for Clinical trials in compliance to protocol, SOPs, ICH-GCP & applicable regulatory guidelines.4.Performing Monitoring and auditing visits at Clinical Sites.5.Preparation of audit reports and Study monitoring reports for the audits and monitoring visits respectively findings in consultation with Clinical Head. 6.Preparation of Standard operating Procedures for Clinical trials activities.7.Internal Quality Check in all departmental activities.8.Track and initiate review and updating of SOPs for Clinical Research Division.9.Filing, maintenance and distribution of Standard Operation Procedures of Clinical Research.10.Develop and maintain GCP/ICH compliant processes which control the quality of work and Internal Departmental training.11.Conduct review of Essential Study Documents of clinical trial such as but not included to Protocol, Investigator Brochure, Case Repot Form, Patient Diary, Clinical study report etc.12.Maintenance of Quality Assurance documentation.If interested can contact on 022-33811403.or can send me your resume on email@example.com Regards, Chaitali Tawade Aspire Management Solutions Pvt. Ltd
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