Manager - Corporate Quality Audit

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.