Manager - Corporate Quality Audit Sun Pharmaceutical Industries Ltd

10.0 - 15.0 years

0 Lacs

karnataka

On-site

As a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd, you will be responsible for overseeing the Gamma Irradiation of Sun Pharma products at third-party gamma irradiation sterilization sites. Your primary role will involve supervising the sterilization process, monitoring the irradiation of batches, and ensuring compliance with quality assurance regulations and auditing techniques. Key responsibilities include: - Demonstrating a sound understanding of pharmaceutical manufacturing processes for both non-sterile and sterile formulations. - Supervising the Gamma sterilization site used for sterilizing drug products and components. - Monitoring the receipt and dispatch of Sun Pharma consignments at the sterilization site. - Reviewing and analyzing irradiation processes and related documentation. - Controlling and monitoring quality systems to ensure compliance with cGMPs. - Participating in investigations for deviations, OOS, and audit findings related to Sun Pharma products. - Reviewing changes in the sterilization process and promptly notifying management. - Assisting in external audit preparations and responding to audit findings. To excel in this role, you should have: - A Bachelor's degree in Pharmacy or a Master's degree in Science. - 10-15 years of industrial experience in formulation and quality systems management. - Exposure to regulatory agency audits such as USFDA, MHRA, ANVISA, TGA, WHO, and ISO. - Familiarity with Trackwise, LIMS, and SAP systems is desirable. - The ability to communicate effectively in a multicultural matrix organization. - Basic computer skills in Microsoft Word, Excel, and PowerPoint. If you are a detail-oriented professional with a passion for ensuring product quality and compliance with regulatory standards, we invite you to apply for this challenging and rewarding position as a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd.,

Posted 5 days ago

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