
Warning letters, 483s, Recalls, Import Alerts, Audit observations
I. Review and monitor monthly production plan for area by considering product demand and available resources to facilitate smooth operations and meet production targets
II. Monitor the daily production operations to ensure efficient operations and delivery as per business need while ensuring compliance to regulatory and statutory norms
III. Monitor all activities to be in adherence to HSE standards and statutory compliance in a block through periodic reviews to avoid accidents & create a safe working environment
IV. Maintain the integrity of online documentation & compliance to cGMP by tracking the systems and controls at unit to meet regulatory and customer requirements and deliver quality product
V. Monitor the maintenance of machines as per standards to avoid uncertainty in operation and adherence to approved budget to reduce overheads
VI. Drive continuous improvements and ensure reduction in process cycle time through unit operational studies to reduce production cost and make the capacity available without CAPEX
VII. Monitor the implementation of plan set for completion of site transfer / IPD projects to ensure on-time launch
Graduate in pharmacy
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