Manufacturing Process Team Leader
Eli Lilly and Company
Total years of experience :19 years, 4 Months
Manage four production departments (Material Preparation, Formulation, Filling, Sorting) and over 30 employees.
Leading a cross-functional process team with members spanning between engineering, supply chain, quality and technical services.
Responsible for and participate in the planning and control of manufacturing operations in Eli Lilly Egypt.
Prepares the business plan for the manufacturing side of production.
Spearhead the sterility assurance and continuous improvement agenda for manufacturing.
Manage and coordinate Six sigma projects related to my area.
Managing the ongoing operation and functions of Lilly Egypt microbiology labs
Ensuring that staff are trained and qualified
Developing procedures and schedules ensuring that all routine processes follow cGMPs
Ensuring that the methods and procedures enforced are up to date.
Managing microbiological investigations, change controls, protocols and validation reports
Scheduling and maintaining the performance of utilities, bulk drug product, raw material, and finished product testing
Scheduling and maintaining the performance of environmental monitoring, validation sample testing, and growth promotion testing
Reviewing and approving microbiological test results for environmental monitoring, raw materials, bulk and finished drug products, growth promotion, and validation testing
Updating, reviewing, and / or approving of microbiology laboratory Standard Operating Procedures, Analytical Methods and Specifications
Evaluating new equipment for purchase and assures that laboratory equipment is maintained calibrated and / or qualified and in good working condition, purchases supplies and equipment
Creating and maintaining microbiology laboratory operational goals metrics for effectiveness and efficiency
Tracking and reporting resource requirements for budget development
Performing batch dispositions providing appropriate documentation.
Managing implementation of laboratory accreditation.
Revising & maintaining Standard Operating Procedures (SOPs).
Investigating and monitoring product quality complaints
Managing stability programs
Managing contract manufacturers
Reviewing, revising and maintaining Product Specification Data Sheets material specifications.
Evaluating and managing deviations & change controls through the appropriate global / local quality systems
Responsible for Corrective Action Tracking.
Maintaining training curriculum
Reviewing and revising environmental monitoring and ongoing quality monitoring data
aseptically raw materials, intermediate and finished products to be analyzed microbiologically.
Preparing media and equipment for sterility testing and analysis.
Testing raw materials, intermediate and finished products.
Preparation of samples for environmental monitoring.
Sterility testing and analysis.
Analyzing water (purified and/or distilled) used for manufacturing of finished products.
Performing biological testing for validation requirement e.g. water system (daily), plant and Q.C autoclaves and/or ovens and media fill.
Ensuring calibration of Equipment.
Performing cephradine trace determination test of production sterile areas.
Preparing for and supervising all the activities done in production whether it is inside or outside the plant.
Ensuring that all materials used and their quantities comply with process batch records and their shop orders.
Participating and manufacturing and packaging batch record creation
Ensuring that all standard operating procedures in the department are done as required.
Applying all steps of In-Process Control
Participating in the departments training and ensure qualification for assigned jobs.
Preparing any Standard Operating Procedures related to the department.
Sharing in investigating and reporting any deviations and changes done in the department.
Ensuring the validity of all raw materials and packaging materials as well as operations performed in the department.
Supervising dispensing of materials from the warehouse for future batches & packaging operations to ensure activities comply with batch records.