Abdullah Oudeh

• -Installed and qualified equipment (IQ/OQ) ensuring compliance with client and GMP requirements.
  Provided client training and completed technical documentation.
  -Diagnosed and resolved equipment issues, minimizing downtime.
  -Handled equipment including: dissolution testers, tablet testers, hardness & disintegration testers, pH & conductivity meters, refrigerators & freezers, biosafety cabinets, leak testers, centrifuges, walk-in chambers, ultrapure water systems, water baths, and sonicators.
• Provided technical support and guidance to clients, enhancing their understanding of equipment operations.
• Performed preventive and corrective maintenance to reduce faults.
• Met daily, weekly and monthly service and repair targets consistently to improve customer satisfaction.

• -Executed Process Validation activities including protocol preparation, in-process monitoring, and final reporting.

Executed process validation activities, ensuring adherence to regulatory standards and enhancing product reliability.

-Followed up all manufacturing stages on production lines to ensure compliance with validation requirements.

-Analyzed process data and provided technical recommendations to improve product quality and consistency.

• -Developed and implemented Cleaning Validation protocols for manufacturing equipment.Performed worst-case product selection and calculated Maximum Allowable Carryover (MACO).-Conducted swab and rinse sampling, reviewed analytical results, and issued validation reports with recommendations.

-Developed and implemented Cleaning Validation protocols for manufacturing equipment.
Performed worst-case product selection and calculated Maximum Allowable Carryover (MACO).
-Conducted swab and rinse sampling, reviewed analytical results, and issued validation reports with recommendations.

• -Performed Qualification & Calibration for various systems and equipment.

Conducted qualification and calibration of equipment, guaranteeing precise measurements and supporting quality assurance initiatives.

-Conducted Thermal Mapping studies for storage areas and temperature-controlled equipment.
Executed HVAC validation and Environmental Monitoring (EM) activities.

-Performed Compressed Air Qualification according to GMP requirements.

-Carried out calibration and qualification for instruments including balances, pH meters, conductivity meters, mixers, and heaters.

• Executed IQ, OQ, and PQ protocols for machines, instruments, and area qualification, ensuring compliance with regulatory standards.
• Conduct and execute Computerized System Validation(CSV) studies.
• Prepared and amended SOPs for validation studies and instrument usage, streamlining processes and ensuring consistency in operations.
• Conduct calibration and verification for instruments.
• Conduct thermal mapping studies for storage devices and storage areas.
• Prepare the Validation Master Plan.
• Coordinated cross-departmental efforts with contractors to track task progress, enhancing project transparency and accountability.

• Identified production issues and implemented effective solutions to optimise operations.
• Identified wasteful practices in production process and proposed solutions for elimination.
• Coordinated team activities across production lines to enhance workflow efficiency.
• Compiled and presented daily production reports to management, highlighting key findings for informed decision-making.

• Planned scheduled maintenance to ensure operational reliability, responded to breakdowns to minimise downtime, and diagnosed faults to restore functionality.
• Documented all maintenance activities, creating comprehensive reports for management review.
• Updated maintenance records and logs to track the history and condition of equipment.
• Managed emergency repairs on critical equipment, often under tight deadlines, to maintain continuous production flow.

• Training
• Completed tasks efficiently and timely, as instructed by engineering managers.
• Participated in weekly team meetings, providing valuable input on project progress and potential improvements.
• Provided assistance in assembly and maintenance of engineering and other technical files.