LAITH SAMARA

• Lead and supervise daily production operations while ensuring full compliance with cGMP requirements, SOPs, safety standards, and company procedures.

• Manage and coordinate production teams to achieve production targets, optimize resource utilization, and maintain efficient workflow.

• Monitor production plans, line performance, and key operational KPIs to ensure adherence to schedules and continuous improvement objectives.

• Manage and support Quality Management System (QMS) activities, including Change Controls, CAPAs, Deviations, Investigations, Production Assessments, and documentation review.

• Prepare, review, and approve production documentation, batch records, SOPs, and operational reports prior to QA submission.

• Develop and review User Requirement Specifications (URS) for new manufacturing and packaging equipment.

• Conduct technical and commercial evaluations, comparison studies, and vendor assessments for new equipment and production line projects.

• Coordinate with QA, QC, Engineering, Validation, Maintenance, Planning, and Procurement departments to ensure smooth operations and successful project execution.

• Analyze production issues and implement effective corrective and preventive actions to minimize downtime, improve productivity, and enhance process reliability.

• Participate in equipment selection, qualification, and implementation activities, including FAT, SAT, IQ, OQ, and PQ.

• Establish and monitor performance benchmarks to drive productivity improvements and operational excellence across production teams.

• Supervise daily production operations, ensuring adherence to SOPs and GMP standards
• Monitor production lines and coordinate workflow to achieve targets efficiently
• Assign tasks and guide production team members, providing training and performance feedback
• Identify and resolve production issues, including equipment malfunctions and process deviations
• Maintain accurate production records, reports, and documentation for QA review
• Collaborate with Quality Assurance (QA/QC), Maintenance, and Planning departments to ensure smooth production
• Implement continuous improvement initiatives to enhance productivity, reduce waste, and ensure product quality

• Receive instructions from the production supervisor and perform the activities as per the Standard Operating Procedures of theequipment/workplace.
• Ensure that the work area and production equipment are cleaned and well-maintained following each operation
• Set up and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs.
• Calculate the required quantities of Raw Material and Primary Packaging Material as per the Bill of Material (BOM) and theBatch record.
• Reserve the required material in the SAP system for preparation by the warehouse.
• Perform all the activities in conformance with cGMPs guidelines and safety guidelines.
• Enter the data / detailsin “Batch Record”/ other records while performing the activity.
• Monitor manufacturing operations, verify and document production activities, including batch records, logbooks, etc., to ensure requirements of production have been met.
• Review and Check Batch records after completing production stages, before delivering the records to the QA department
• Maintain proper hygiene and cleanliness as required by cGMPs in the workplace.
• Report any incidence of non-conformance to the supervisor. •Follow the correct procedures of entry, exit, material handling, and movement within the department.

• Ensure that the work area and production equipment is cleaned and well-maintained following each operation
• Setup and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs
• Perform all the activities in conformance with cGMPs guidelines and safety guidelines
• Enter the data/details in 'Batch Record'/ other records while performing the activity
• Monitor manufacturing operations, Verify & document production activities, including batch records, logbooks, etc. to ensure requirements of production have been met
• Follow the correct procedures of entry exit, material handling and movement within the department