Areas of Responsibility

· To conduct the Quality audits of Clinical Pharmacology Units including Pathology and Bio- analytical Laboratories and Pharmacovigilance function of Sun Pharma sites as per the approved annual plan.

· To ensure regulatory compliance with respect to Clinical and Pharmacovigilance functions.

· To support these sites during regulatory inspections by planning site review

· To participate in Sun sites audits, (need base)

· To ensure that audit findings are based on facts and with respect to regulatory requirements

· Categorization of non-conformity in to Critical, Major and Minor, appropriately.

· To prepare audit report, review of response received from site within timeline.

· To ensure audit closure after receipt and review of satisfactory compliance.

· To ensure maintenance / update of the records/ documents pertaining to audit life cycle.

· To perform the trend analysis of audit observations.

· Participate and support project work as allotted by reporting authority.

Educational Qualification: B.Pharm / M.Pharm
Experience: 15+ Years of experience See Less