Manager - Corporate Quality Audit [Urgent Search]

4 weeks ago

Bengaluru India SUN PHARMA Full time

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.

  • Manager - Corporate Quality Audit

    4 days ago

    Bengaluru, Karnataka, India sun pharmaceutical ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description Sun Pharma Corporate Quality Department Position: Manager (G10)Effective Date: Department: Corporate QualityLocation: 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...

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