Manager - Corporate Quality Audit

Job Description

Sun Pharma Corporate Quality Department Position: Manager (G10) Effective Date: Department: Corporate Quality Location: Bengaluru, Reporting Manager Title: GM - Corporate Quality Classification: Manager - Corporate Quality (Gamma Irradiation) Job Summary: Manager Corporate Quality - Individual Performer Role Responsible for oversight of Gamma Irradiation of Sun Pharma products at third party gamma irradiation sterilization. Essential Job Functions: Should possess sound knowledge of pharmaceutical manufacturing process (Non-sterile & Sterile formulations) & quality assurance regulations and auditing technique. Responsible for the overall supervision of Gamma sterilization site (Third party) used for sterilization of drug product and other components, as required. To monitor receipt and dispatch of consignment of Sun Pharma at Gamma sterilization site. Review and monitoring of irradiation process of the batch and related documentation. Review and monitor of analytical data (Dosimeter Testing) Control and monitor quality systems which enable operations on site to occur in an efficient manner and in compliance with cGMPs. Follow-up for timely closure of QMS documents. Participating in the investigations for Deviations, OOS and Audit findings related to Sun Pharma product/s. Review of changes in gamma sterilization process / major modification at site and timely notification to the management. Supporting in external audits preparations and responding to audit findings of gamma serialization sites Should be able to travel to third party site/s. Basic computer skills (Microsoft word/ Excel/ Power point presentation) and ability to learn and become proficient with appropriate software. Should possess good verbal and written communication skills. Basic Qualification: B. Pharm / MSc Industrial Experience & Knowledge: Minimum work experience of 10-15 Years in formulation & quality systems management operations. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, ANVISA, TGA, WHO, ISO etc. Knowledge of Track wise/LIMS/SAP is desirable. Ability to work effectively in multicultural matrix organization.