Taking lead in executing batch runs for the production facility. Managing and developing staff within the team. Scheduling staff to the appropriate areas and process suites.Managing all personnel, material and product flow throughout the downstream manufacturing area for various projects. In conjunction with management, ensuring all functions and related documentation are completed accurately and in a timely manner to achieve production targets and regulatory requirements. Ensuring that all… Show more Taking lead in executing batch runs for the production facility. Managing and developing staff within the team. Scheduling staff to the appropriate areas and process suites.Managing all personnel, material and product flow throughout the downstream manufacturing area for various projects. In conjunction with management, ensuring all functions and related documentation are completed accurately and in a timely manner to achieve production targets and regulatory requirements. Ensuring that all manufacturing staff member’s training is validated prior to working in an area.Working closely with production management to develop departmental initiatives and strategies to increase efficiencies.Coordinating with the Facilities Department to ensure all equipment and suites are maintained according to established standards and schedules.Enforcing health and safety adherence and compliance.Identifying equipment issues and taking appropriate action to resolve.Maintaining appropriate standards within the team and the processes they are involved with.Assisting in investigations concerning manufacturing issues.Assisting in the IQ/OQ/PQ of production equipment.Maintaining active role in all downstream manufacturing activities.Handling and managing projects simultaneously by providing technical expertise and providing executive path while achieving timeline.Vigorously involved in SME group, Client and higher management to initiate, lead and enforce CI (Continuous Improvement) projects to increase efficiency and divert valuable resources for maximum utilization. Show less

Provided Technical Training to team members.Overseeing Downstream Technicians and closely involved in the execution of Manufacturing batches.Drafted and reviewed Protocols, Batch Production Records, Reports and investigations as needed.Assisted documentation team for drafting Deviation Reports and Notice Of Events.Communicated clear instructions to team members, and within the organization, to ensure that all manufacturing activities are well coordinated.Participated in… Show more Provided Technical Training to team members.Overseeing Downstream Technicians and closely involved in the execution of Manufacturing batches.Drafted and reviewed Protocols, Batch Production Records, Reports and investigations as needed.Assisted documentation team for drafting Deviation Reports and Notice Of Events.Communicated clear instructions to team members, and within the organization, to ensure that all manufacturing activities are well coordinated.Participated in equipment and process troubleshooting as well as provided support to production management in process improvement activities Show less

Provided Technical Training to team members.Overseeing Downstream Technicians and closely involved in the execution of Manufacturing batches.Drafted and reviewed Protocols, Batch Production Records, Reports and investigations as needed.Assisted documentation team for drafting Deviation Reports and Notice Of Events.Communicated clear instructions to team members, and within the organization, to ensure that all manufacturing activities are well coordinated.Participated in… Show more Provided Technical Training to team members.Overseeing Downstream Technicians and closely involved in the execution of Manufacturing batches.Drafted and reviewed Protocols, Batch Production Records, Reports and investigations as needed.Assisted documentation team for drafting Deviation Reports and Notice Of Events.Communicated clear instructions to team members, and within the organization, to ensure that all manufacturing activities are well coordinated.Participated in equipment and process troubleshooting as well as provided support to production management in process improvement activities Show less

- Teamwork- Customer services- Communication- Data record and reporting- Baking- Store keeping

- Sample analysis for intermediate, raw materials and finished products as directed by GMP.- Cleaning validation- Dissolution, Disintegration, Hardness, Friability testing - I have performed HPLC, Karl Fisher, UV/Vis, FT-IR Spectroscopy, Column, and TLC for product analysis.- Documentation including data record according established SOP under GLP.- Lab records including log books