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Performs validation exercises of production and lab equipment, utilities, packaging and processes to ensure specific standard of compliance is met.


Job requirements: 


Planning and Operational Support

  • Act as a technical/ subject matter resource
  • Facilitate implementation of current processes
  • Identify gaps in current policies and procedures
  • Provide input into changes or improvements to processes, tools and techniques



  • Perform validation exercises in compliance with GMP standards and validation schedules
  • Maintain compliant status of equipment and processes



  • Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use
  • Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits
  • Investigate and report OOE results, and perform re-tests
  • Participate in change control assessments to ensure compliant status of affected equipment is not compromised
  • Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
  • Ensure documents and procedures to operate and maintain equipment are in place



  • Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol
  • Prepare and perform re-qualification of equipment and utilities as per SOP


Reporting and Record-Keeping

  • Compile, maintain and update validation documentation as per SOP and QMS
  • Generate validation reports on a weekly/ monthly basis


Skills Required


  • National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
  • Degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
  • Aseptic pharmaceutical manufacturing process and automated packing experience will be advantageous


Specific job skills

  • Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
  • Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
  • Pharmaceutical standards and compliance requirements
  • Ability to interpret and implement policies, processes and objectives



  • Interrogating information
  • Maintaining accuracy
  • Following procedures
  • Technical writing

Reference Number: 



Aspen Pharma Group


Port Elizabeth




Market Related

Job Type: 



Pharmaceutical And Medical/Healthcare


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