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Validation Unit Head

Rameda
6th of October, Giza
Posted 3 years ago
27Applicants for1 open position
  • 5Viewed
  • 1In Consideration
  • 20Not Selected
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Job Details

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Job Description

  • Participating in: GMP Projects, Different Validation Working Parties.
  • Checking and follow up the site validation review plans for (building, HVAC system, services and equipment).
  • Prepare, review and update the Validation Master Plans (VMP),design qualification , installation Qualification & operation Qualification and Performance Qualification Protocols (PQPs) and Validation reports (VR) for different validation activities such as:
  • Process validation.
  • Cleaning validation.
  • Validation Review.
  • Facility Qualification.
  • Thermal Mapping.
  • Media fill.
  • Internal & External Calibration.
  • Internal & External Qualification.
  • Annual product quality review (APQR).
  • Water System Performance Qualification Protocol and report (phase 1, phase 2).
  • Holding Time for Pharmaceuticals during Manufacturing Process.
  • Skip Testing Pharmaceutical Industry Validation Protocol & Report.
  • Up the following activities to review and approve them:
  • Receiving all calibration certificates, follow its approval and filing.
  • Filing all validation deliverables and retrieving them professionally.
  • Review and approved for all Qualification report.
  • Review and approved for all Calibration report.
  • Review for all new batch production record.
  • Review for all new standard operating procedure related the validation section.
  • Review for all new standard formulas.
  • Following up closing of change control incomplete implementation requirements concerning validation activities.
  • Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001, OHSAS 18001)

Job Requirements

  • QA Validation Unit head -- Exp from 5-8 years 
  • Bachelor degree in science or pharmacy
  • Males only

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