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Senior QA Validation Specialist

Orchidia Pharmaceutical Industries
Obour City, Cairo
Posted 4 years ago
89Applicants for1 open position
  • 41Viewed
  • 9In Consideration
  • 32Not Selected
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Job Details

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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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