Job 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.
Executive & Technical Duties
- Organize all jobs within the validation division.
- Cooperate with related department heads for planning schedules and implementation of validation works.
- Prepare IQOQ and PQ documents for all production machines, laboratory instruments, and utilities.
- Ensure that all validation activities and recommendations are followed.
- Ensure adequate training for validation division employees.
- Ensure that all validation instruments are calibrated.
- Review all documentation related to the validation division, such as VMP, protocols, etc.
- Prepare SOPs related to validation activities.
- Follow up on the execution of validation plans and make the required arrangements for that.
- Conduct and control validation studies following the related SOPs, protocols, and policies.
- Prepare and execute manufacturing process validation protocols.
- Prepare and execute cleaning validation protocols.
- Prepare and execute software and computerized systems validation protocols.
- Adhere to the current good manufacturing practices in all activities.
General Administrative Duties
- Ensure compliance with relevant national and international health, safety and environmental laws and policies as well as maintain the records and reports of HSE aspects.
- Perform other duties or tasks as assigned by the direct supervisor.
Professional Knowledge
- 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
Qualifications
- BSc in pharmacy, chemical engineering, Mechatronics engineering or any related field as per the country regulations
- A minimum of two years experience in a related field.
- Proficiency in written, read and spoken Arabic and English.
