Validation Officer

2 weeks ago


Port Elizabeth, South Africa Fresenius Group Full time
Job title : Validation Officer Job Location : Eastern Cape, Port Elizabeth Deadline : December 08, 2024 Quick Recommended Links
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General Duties:

  • Development of User Requirement Specifications
  • Development of Manufacturing Procedures
  • Qualification and re-qualification of equipment and utilities
  • Development and execution of System Impact Assessments and Component Impact Assessments
  • Development and execution of Validation Risk Assessments and Design Reviews
  • Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
  • Development and execution of Process Validation studies
  • Validation of computerised systems validation
  • Validation of Automated System
  • Validation of sterilisation equipment and cycles
  • Performance of Factory Acceptance Testing
  • Control of delegated Validation Plans
  • Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack

Requirements

  • A Life Science or Chemical Engineering degree or equivalent. 
  • 3-5 years of experience of validation in the pharmaceutical industry.
  • Knowledge of production processes
  • Systems, product, industry and equipment knowledge
  • Use of statistical techniques
  • Knowledge of analytical, technical and engineering methods

Competency requirements are as follows:

  • Attention to detail
  • Time Management
  • Planning skills; Problem solving
  • Organizational skills; communication Skills
  • Protocol and technical report writing skills and Computer literacy

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