Review the cycle time of new products and update same in production schedule.
Inventory control & external warehouse material movement
Plan and coordinate day-to-day for production to meet the company’s expectations for safety, productivity, quality, and goal achievement and exceed our customers’ expectations.
Responsible for production schedule, material arrangement and release follow-up, to dispatch the products on time.
Responsible to maximum utilization of resources.
To receive 3 months commercial rolling plan from SCM and one month R&D plan from Project team for production schedule.
Responsible to prepare production schedule and share with CFT with month commitment.
To follow Document team and CFT for document approval as per production schedule.
To create and release process order for commercial, validation, submission, and engineering batches in ERP system.
Responsible to issue batch document for commercial products as per plan.
Coordinate cross functional teams for CoA, executed document for batch release and dispatch.
Follow with Logistic and warehouse team for container arrangement for Air and sea shipment.
Ensure to track the process, analysis, and dispatch of less DOH products.
Maintain safe and healthy work environment by ensuring regulatory and company standard and practices are adhered to.
Allocate resources for NPL products to balancing commercial requirement and submission timeline.
Initiate Quarantine dispatch request for internal and EVL approval, whenever required for priority products.
Notification to management for any critical and major issues related to delivery.
Maintain transparent communication. Appropriately communicate information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
Other jobs assigned by superiors to support the organization achievement as well as cooperation in company rule and regulations, safety policy and all activities according to company policy.
Monthly dispatch batches and volume to be meet as per the plan.
Ensure implementation of adequate and effective training programs related to cGMP.
Review and update department HOD for plan Vs actual and delays.
Review the cycle time of new products and update same in production schedule.
To ensure all Qualification related activities to close on time for area release for commercial.
Quality and Compliance
Meeting statutory requirements.
cGMP Compliance in entire manufacturing area and SOP compliance on all aspects.
To ensure zero overdue on training assigned.
Follow ALCOA++ and ready for any time inspection.
Responsible to face regulatory and customer audits.
Ensure to follow quality culture in organization.
Safety
To ensure 100% safe operation in production area.
Ensure all the necessary PPEs are available in production facility and monitor proper PPEs are worn by the personnel’s during manufacturing.
Reporting the near miss and ensure their compliances.
Follow ISO 14001 practices.
To follow and maintain 5s in workplace.