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Senior QA Cleaning Validation

Jamjoom Pharma
Obour City, Cairo
Posted 2 years ago
65Applicants for1 open position
  • 24Viewed
  • 8In Consideration
  • 16Not Selected
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Job Details

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Job Description

Responsibilities:

  • Prepare Cleaning validation master plans, core validation master plans and additional supporting documentation.
  • Prepare Cleaning Validation Protocols and Reports for Oral Dosage form products.
  • Prepare Cleaning Validation Protocols and Reports for Dermal products.
  • Prepare Cleaning Validation Protocols and Reports for Eye Drops products.
  • Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required.
  • Ensure change controls are assessed for impact on validation.
  • Preparation and performing Periodic Cleaning verification plan in accordance with validation master plan.
  • Scheduling, planning, managing, and executing studies for Media fill and Gowning qualification.
  • Generates executes and/or reviews master and completed Media fill protocols, Gowning qualification protocol, summary reports, associated data, deviations for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Preparation of SAP validation and verification protocols and reports.
  • Preparation of software validation protocols and reports.

Job Requirements

  • Bachelor’s degree of pharmacy                                                                                 
  • Years of experience not less than 4 years in the same field. 
  • Have a professional trainings in GMP, GDP, GEP
  • Awareness with updated regulations [WHO, FDA and EU guidelines] and guidelines [ISPE, PICs, ICH and ISO].
  • Good command of English (spoken and written).
  • Good Computer user or related machines required.
  • Ability to analyze, and interpret statistical data.       

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