Samer Dairi

In my role as a Validation and Qualification Engineer, I was responsible for developing and implementing SOPs and protocols, overseeing machinery verification, calibration, and qualification, and conducting process validation for the company's products. Additionally, I served as an QA specialist, conducting in-process control inspections to ensure adherence to quality standards.

My main responsibilities encompassed the following:

As Qualification/ Validation Engineer:

• Developed and implemented SOPs and validation protocols.
• Executed validation studies to ensure consistent product quality.
• Ensure compliance with regulatory standards and guidelines.
• Participate in change control and validation procedures.
• Uphold high standards of quality and compliance.
• Execute validation studies to ensure consistent product quality.
• Define critical process parameters and quality attributes.
• Collect and analyze data using statistical tools.
• Conduct risk assessments and implement mitigation strategies.
• Maintain comprehensive documentation and prepare validation reports.
• Drive continuous improvement in manufacturing processes.
• Collaborate with cross-functional teams and communicate validation findings.
• Maintain comprehensive documentation and records of validation, qualification and calibration activities.
• Provide training and support to personnel involved in validation, qualification and calibration.
• Perform qualification activities on equipment, instruments, and machines.
• Calibrate critical instruments and devices used in pharmaceutical processes.
• Ensure accurate and reliable equipment for manufacturing and testing processes.

• I worked as part of a team within the GMP Compliance Department, overseeing operations across four separate factories. and was able to cover all areas and production stages, including weighing, mixing (granulation, drying, final mixing, liquid mixing), tablet compressing, IPC, coating, capsule filling, primary packaging (blister filling, jar filling, dry suspension filling, liquid filling), secondary packaging (printing, track & trace, folding, labeling, box/HP packaging, carton packing, carton aggregation, pallet aggregation).

My main responsibilities encompassed the following:

• Verify line clearance
• Verify calibration of machines and equipment
• Verify environmental monitoring (temperature, humidity, differential pressure)
• Perform inter-tests in IPC laboratory (thickness, hardness, diameter, weight variation, disintegration, friability, visual inspection, leakage, LOD)
• Verify storage between production stages
• Check employee work and training conformity with GMP
• Verify machines' process parameters
• Check raw materials and packing materials
• Verify documentation accuracy
• Check maintenance requests
• Verify change control requests
• Conduct infrastructure verification
• Check cleanliness of production facilities
• Verify samples sent to quality control department
• Verify quantities of raw materials, packaging materials, and finished products delivered to warehouses.