Quality Assurance Manager

Job Description

Job role:GM QA / Corporate QA Job responsibilities: To manage the functions of GCP/ GLP Quality Assurance program that will assure all BA/BE studies and clinical studies can withstand regulatory scrutiny. To manage GCP/ GLP inspections of different regulatory bodies like USFDA, WHO, Brazil etc. and second party sponsor audits. To interpret relevant regulations and apply them to create specific Quality Assurance SOPs and policies that adhere to regulatory guidance. Documentation and record-keeping requirements are met internally to support regulatory submissions. Coordinate periodic Quality Management reviews to ascertain the compliance status to management. To schedule and conduct independent audits of all departments, facility and vendors as per SOP. To approve all SOPs for adequacy and GCP / GLP / GCLP compliance and impart training on quality assurance principles and auditing procedures to new and existing personnel. To ensure that the study is conducted without any deviations from approved protocols or standard operating procedures. To review and authenticate all the study reports to assure that such reports accurately describe the methods, SOPs and protocol and that the reported results accurately reflect the raw data of the conducted study. Conducting the management meeting to set up the goals and monitor the progress of the projects. To ensure that all the staff in ICBio are adequately trained and provided refresher trainings on SOPs, work instruction and regulatory guidelines. Response to the regulatory queries and ensure CAPA. Other Responsibilities: assigned time to time by the Head of the Department and/or Management. Interested candidates can shared resumes at jhelam.s@randstad.in