 Handling Project timelines and responsibilities for work distribution, training, meeting project and Method Validation timelines, coordinating with other departments. Support QA Head/ Incharge for responding to regulatory or sponsor queries/audit reports/audit observations. Support QA Head/ Incharge for preparation and review of QA SOP’s, system SOP’s of General Administration Department, Clinical SOP, and Project Management and Biopharmaceutics SOP’s for adequacy, correctness and completeness. Plan and conduct audit of study protocol/SOP/Study Plan and retrospective audit of Clinical raw data as well as Clinical Study report as per regulatory guidelines, in house SOP’s and Protocol/Plan. Plan and conduct in process audit of various Clinical phases. Plan and conduct system audit of various section of Clinical Research Department, General administration department and Project Management and Biopharmaceutics department as per the schedule, prepare audit report and ensure compliance for the same. Plan and conduct vendor audit of various vendor/ service provider as per schedule and prepare audit report and recommend to management whether vendor/ service provider qualified or not. Train QA auditors and others on in house SOP’s / system. Review validation and calibration dockets of the instrument/equipment of all departments for compliance. To prepare audit reports and forward the audit observations to respective department. Suggesting modification in the current process to improve quality and to minimize the errors. Preparation of Checklists for Quality Assurance Audits. Issue, distribution and reconciliation of SOP, Forms and logbook. Preparation of deviation report and present in the Management Review Meeting. Any other responsibility assigned by the QA Head / Incharge.

 Developing Quality Management System Implementation and development of CAPA plan. Handling of Sponsor Monitor and Auditor during System Audit. Deviation Management and Analysis. To set scheduled and deadlines of the project and allotment of task duty to auditor Review of bio study protocol (BABE) and Informed Consent Form Audit of Clinical Study Report (CSR), Pharmacokinetic and Biostatics Report, DBE table, Module2.7.1 and e-CTD compilation (module 5) and authentication of projects Verification of CIDISC data Carry out in-process and retrospective audits various clinical phases of biostudy as per auditschedule Carry out follow up audits for verification of corrective and preventive actions Preparation and review of clinical, general and QA SOPs Carry out system audits of in-house contracted facilities and vendors Generation, distribution, retrieval and archival of SOPs forms, logbooks, protocol and any otherdocuments