Mohammed Zaben
Validation and Calibration Supervisor
Amman
Summary
Hard-working Validation and calibration supervisor with exceptional experience leading teams, delivering results and exceeding expectations. Succeeded to pass the several audits, Experienced in establishing validation, machine qualification, environment qualification, calibration procedures for manufacturing areas and laboratories.
Overview
10
10
years of professional experience
5
5
years of post-secondary education
2
2
Languages
Work History
Validation & Calibration Supervisor
Hikma Pharmaceuticals Company
Amman
11.2020 - Current
- Plan and schedule validation projects, including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGMP requirements.
- Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.
- Review of validation documentation associated with all validation activities, PM, and calibration to ensure completeness, accuracy, cGMP compliance, data acceptability and conformance to FDA procedures and requirements.
- Carry out validation activities of equipment and systems IQ, OQ, PQ’s to maintain compliance in all manufacturing areas and complete validation reports and resolution of deviations.
- Prepare Analytical Instruments Qualification Protocols and reports Based on EN , Bp, USP Guidelines
- Prepare Uncertainty Measurements for Standard Calibration Methods.
- Environment qualification to comply with (WHO , ASHAR , ISO 14644)
- Prepare Method Validation procedure for Analytical Methods
- Sterilization processes qualification ( Steam , Dry Heat , UV,ACV,LPH)
- Prepare Calibration SOPs Based on International Guidelines ( OIML, NIST)
- Maintain Calibration Management database e.g. enter, change, and update equipment status.
Calibration Senior Engineer
Hikma Pharmaceuticals Company
Amman
07.2020 - 11.2020
- Performing routine calibration of instrumentation and equipment, including but not limited to pressure gauges, temperature sensors, and flow meters.
- Documenting calibration processes and maintaining records of calibration certificates, reports, and work orders.
- Developing calibration methodologies and procedures for various instruments and equipment to ensure precision and accuracy in measurements.
- Collaborating with quality assurance teams to ensure compliance with industry standards, regulatory requirements, and company policies.
- Conducting uncertainty analysis and ensuring that all measurements are traceable to national or international standards.
- Performing the thermal validation and heat penetration studies of the autoclaves, dry heat and vacuum ovens and sterile machines Using Ellab System (TS Pro loggers and EVP)
Calibration Engineer
Hikma Pharmaceuticals Company
Amman
04.2015 - 07.2020
- Performing routine calibration of instrumentation and equipment according to ISO 17025.
- qualified in performing the calibration in sterile production and clean rooms and other plants
- Designing and executing validation studies to confirm the reliability and accuracy of measurement systems and equipment.
- Specifying and sourcing calibration standards and equipment required for performing accurate calibrations.
- Training technicians and other personnel on proper calibration techniques and the use of calibration equipment.
- ▪ Implementing all calibration tests for different instruments such as, torque meters, tablet testing systems, leak testers, chart recorders, data loggers, humidity and temperature generators, balances, and refrigerators.
- Prepare the risk assessment reports, and investigation analysis.
Calibration & Maintenance Engineer Trainee
Hikma Pharmaceuticals Company
Amman
06.2014 - 09.2014
Education
Bachelor's Degree - Electrical Engineering -Power and Control
Jordan University of Science and Technology
Irbid,Jordan 09.2009 - 06.2014
Skills
SAP ERP system
courses
▪ HVAC Validation & Requalification and Design (AGON Academy).
▪ Data Integrity (AGON Academy).
▪ Technical & business Writing. (Pioneer Academy).
▪ Uncertainty & measurements (Jordan national meteorology institute).
▪ Calibration Standards and Procedures(Jordan national meteorology institute).
▪ Current Good Manufacturing Practice.
▪ Supervisory Management skills.
▪ English Course (Berlitz Academy).
▪ Ellab System Solution (Track sense + EVAL PRO) Modules for Thermal Validation Studies.
▪ Communication skills course.
▪ Advanced Excel course.
▪ Water Treatment. (HIKMA pharmaceuticals)
▪ Pharmaceutical Manufacturing Process. (HIKMA pharmaceuticals)
▪ Risk Assessment. (HIKMA pharmaceuticals)
Timeline
Validation & Calibration Supervisor
Hikma Pharmaceuticals Company
11.2020 - Current
Calibration Senior Engineer
Hikma Pharmaceuticals Company
07.2020 - 11.2020
Calibration Engineer
Hikma Pharmaceuticals Company
04.2015 - 07.2020
Calibration & Maintenance Engineer Trainee
Hikma Pharmaceuticals Company
06.2014 - 09.2014
Bachelor's Degree - Electrical Engineering -Power and Control
Jordan University of Science and Technology
09.2009 - 06.2014
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