Validation Engineer
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Description
Carry out the required validation tests and perform installation and operational protocol duties, analyze the results of testing and determine the acceptability of results against predetermined criteria in a timely manner and in compliance with cGMP and SOPs and manufacturing instructions.
BSc in pharmacy, chemical engineering, Mechatronics engineering or any related field as per the country regulations
0-2 years experience in a related field.
Good written, read and spoken Arabic and English.
Required Experiences
Carry out the required validation tests and perform installation and operational protocol duties, analyze the results of testing and determine the acceptability of results against predetermined criteria in a timely manner and in compliance with cGMP and SOPs and manufacturing instructions.
- Prepare the Validation Master Plan (VMP).
- Prepare and execute qualification (IQ, OQ, PQ) and requalification protocols for production machines and analytical instruments in coordination with Production, Quality Control, and R&D.
- Conduct validation studies following related SOPs, protocols, and policies.
- Prepare SOPs related to validation activities.
- Follow up on the execution of validation plans and make the required arrangements for that.
- Conduct temperature and relative humidity mapping studies for warehouses and stability chambers and prepare protocols for validating the method of storage in warehouses and stability chambers.
- Prepare and execute utilities qualification protocols, manufacturing process validation protocols, cleaning validation protocols, and software and computerized systems validation protocols.
- Check and follow up on air and water quality validation.
- Ensure that all validation tools and instruments are kept clean and in good condition.
- Follow up on the calibration of validation instruments in order to execute all validation tasks using properly calibrated equipment.
- Report to the Manager of Validation any deviations from SOPs, protocols, or policies.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Coordinate with external entities responsible for analytical devices marketing to conduct qualification studies for new devices.
- Adhere to the current good manufacturing practices in all activities.
BSc in pharmacy, chemical engineering, Mechatronics engineering or any related field as per the country regulations
0-2 years experience in a related field.
Good written, read and spoken Arabic and English.
Required Experiences
- Knowledge in (ISO 14001) system
- Ministry of Health Regulations
- Ministry of Environment’s Regulations
- Knowledge in ISO 14001, I14644-1, -2, -3, & -4
- FDA Regulations
- Knowledge in the systems such as ICH, GMP, GLP, WHO
- Process, design, installation, operation, manufacturing machines, utilities
geo
in Jordan , Amman city
number of positions
1 Jobs available, apply now
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Jobs in Jordan
2 weeks ago
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