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Quality Assurance Validation Specialist

Nerhadou International
6th of October, Giza
Posted 9 months ago
212Applicants for1 open position
  • 1Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

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Job Description

  • Execute validation studies throughout the facility.
  • Interact with relevant levels staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, and support for identified validation projects.
  • execute validation tasks in different projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.
  • Interface extensively with the QC/QA, Production and engineering departments to execute validation tasks and problems requiring validation support.
  • Align with priorities to ensure critical projects meet required deadlines.
  • implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes.
  • prepare the protocols and reports for process validation, hold time study, campaign length cleaning validation, IQ/OQ and performance qualification.
  • Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors .
  • Follow up overall qualification/validation activities include (HVAC, thermal mapping, machine qualification, laboratory instrument qualification, etc….).
  • Ensure appropriate testing with quality control and support methods validation with R&D department is completed.
  • execute the facility qualification program by preparing the protocols, monitoring the execution, and assisting production and engineering in resolving any identified problems
  • Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities,
  • Ensure critical deadlines are met for complex projects with quality assurance manager supervision.

Job Requirements

  • Bachelor of pharmacy or science.
  • 1-3 years of experience.
  • Proven work experience as a Quality Assurance Specialist or similar role
  • Working knowledge of tools, methods and concepts of quality assurance
  • Solid knowledge of relevant regulatory standards
  • Good communication skills, both verbal and written
  • Excellent data collection and analysis skills
  • Strong attention to detail
  • Relevant training and/or certifications as a Quality Assurance Specialist

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