Job summary
Ensure that process and cleaning validation activities at EL KENDI are carried out to a common standard and are in compliance with the requirements of GMPs.
Main Duties
- Prepare the whole process and cleaning validation documents such as; protocols, reports, standard operating procedures (SOPs) and their related subsequent documents.
- Prepare matrixing and bracketing reports as per the appropriate approaches for process validation.
- Prepare of annual product quality review report.
- Process validation data report check.
- Closing of complete process validation protocols.
- Process and cleaning validation activities field monitoring
Requirements
Education: Pharmacy, chemistry, pharmaceutical process engineering, Chemical Engineering, other related science requested.
Languages: Fluent in Arabic, French and English (written and spoken)
Experience: 0-2 years of relevant experience in pharmaceutical industry
Knowledge
- Knowledge in documentation control systems
- Knowledge in good documentation practices
- Knowledge in process validation.
- FDA regulations.
- EMA regulations.
- ICH regulations.
- Knowledge in basic statistic and quality tools.
Technical Skills
- Good Documentation Practices
- Ability to handle multiple interrelated tasks and in complex timeframes while maintaining the quality of work
- Ability to meet the deadlines of tasks and activities with the expected level of quality
- Computer skills
Behavioral Skills
- Strong team player with good communication skills
- Agility
- Flexibility and adaptability
Start your application by sending your CV to [email protected] and keeping the job title on Email’s subject.