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Department: Production

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1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs.

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1. Analysis of stability/Finished product samples and compile the report as per ALCOA procedure, other miscellaneous samples and compile their report.

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• Ensure readiness of equipment and instrument for process.

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GMP Compliance – Drug Product Facility

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• Lead end-to-end brand management of assigned portfolio to drive market share growth, therapy expansion, and profitability

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Developing the plan / strategy for the brand ( Operational and Strategic Plan) & gaining support from internal and external stakeholders

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• Analytical method development and validation for dissolution/in-vitro release using USP Type I, II, IV, shaking water bath, bottle rotating apparatus, or other suitable techniques. Particle size distribution and Zeta potential (Mastersizer/Zetasizer), Viscosity (Rheometer/Brookfield), Assay and degradation product/content testing, including preservative and antioxidant analysis for complex injectables (Including Suspensions, Emulsion, Microsphere and LAI).

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1. Manage technology transfer of pharmaceutical products from R&D to manufacturing sites.

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• Prepare pre-shipment custom documents for export shipments and coordinate with the respective CHA.

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• Coordinate the implementation, execution, and completion of projects on time and within the allocated budget.

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Responsible for achieving API production targets while ensuring compliance, safety, quality, cost control, manpower management, and continuous improvement initiatives across manufacturing operations.

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1. To act as a connecting link between the Team leader, junior physios and patients

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f steOperation of steam sterilizer & preparation of sterilizer loads.

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