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Job Description
Prepare validation plans/protocols in cooperation with concerned departments for the production processes such as:
- Process validation
- Cleaning validation
- SIP , CIP & Filtration validation
- Prepare plan for revalidation activities
- Supervise qualification activities during execution.
- Prepare media fill validation protocol in cooperation with concerned department manager
- Prepare VMP for the facility as per latest guideline.
- Prepare all needed SOP for validation activities in the plant.
- Supervise the investigation team in items related to validation activities
- Prepare action plan
- Participate in CAPA system
- Follow up implementation
- Prepare all documents/SOPs needed for annual product review process.
- Perform annual product review for company’s products on regular basis through using SPC method to determine trends and issues and issue a report to QA manager on regular basis.
- Analyze all needed data and prepare reports for QA manager
Job Requirements
- Bachelor Degree of pharmacy or science
- at least 3 years of experience in Validation
- Understanding of methodologies and best QA practices
- Knowledge of documentation reviews and requirements analysis.
- Ability to troubleshooting and resolving complex issues effectively.
- Excellent English, verbal / written communication
- Ability to work well through others
- Excellent computer skills
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