Ali Saleh
Ras Al-Khaimah
Summary
Analytical and Research Supervisor with 16 years in pharmaceutical manufacturing and laboratory management, specialising in method development, validation, and stability testing. Led teams and coordinated cross-functional projects, ensuring compliance with cGMP, cGLP, and ICH guidelines while supporting regulatory interactions and providing analytical expertise in complex environments.
Overview
2
2
Languages
16
16
years of professional experience
Work History
Research and Development Supervisor
Julphar Pharmaceutical Industries
Ras Al-Khaimah, United Arab Emirates
07.2019 - Current
- Led method development, validation and stability activities, ensuring compliance with ICH guidelines and pharmacopoeia standards.
- Developed and implemented SOPs, training staff on analytical techniques and regulatory standards.
- Ensured adherence to cGMP, cGLP, and GDP in daily laboratory operations, maintaining high quality standards.
- Oversaw investigations into Out of Specification (OOS) results, employing scientific judgment to identify and resolve issues effectively.
- Coordinated stability testing schedules and streamlined analytical workflows to enhance laboratory operations.
- Collaborated with regulatory teams on submission documents and regulatory responses, ensuring compliance with health authority requirements.
- Reviews SOPs, stability studies, validation documentation, change controls, deviations/CAPA and investigations to maintain compliance.
- Developed new analytical methods in-house to enhance laboratory capabilities.
- Prepared method validation reports for new product projects to ensure compliance..
- Evaluated Analytical Technology Transfer Documents to ensure seamless execution of analytical activities..
Supervisor - Analytical Research (AR)
JOSWE Pharmaceutical
Amman, Jordan
07.2010 - 07.2019
- Managed all analytical activities within the laboratory, overseeing method development, validation, and stability testing.
- Prepared and reviewed technical documentation for new products, ensuring compliance with regulatory guidelines and facilitating successful product launches.
- Coordinated with regulatory affairs to ensure timely submission of product dossiers and updates.
- Reviewed and revised SOPs, stability studies, and validation reports to maintain regulatory compliance and enhance laboratory standards.
- Trained junior analysts, fostering a team-oriented environment focused on quality and accuracy.
- Ensured calibration and maintenance of analytical instruments such as HPLC, GC, and UV-Vis, maintaining operational readiness.
Education
BSC - Chemistry
Al albayt university
JordanSkills
- Analytical Method Development
- Method Validation
- Stability Testing
- Regulatory Compliance
- cGMP, cGLP, GDP
- Analytical Technology Transfer
- Instrument Calibration
- Laboratory Management
- Troubleshooting
- Team Leadership
Languages
Arabic
First Language
English
Advanced
C1
Timeline
Research and Development Supervisor
Julphar Pharmaceutical Industries
07.2019 - Current
Supervisor - Analytical Research (AR)
JOSWE Pharmaceutical
07.2010 - 07.2019
BSC - Chemistry
Al albayt university