Validation Officer

3 weeks ago


East London, Eastern Cape, South Africa Aspen Pharma Group Full time

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

Responsibilities

Planning and Operational Support

  • Facilitate implementation of current processes
  • Identify gaps in current policies and procedures
  • Provide input into changes or improvements to processes, tools and techniques

Validation

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

Qualification

  • 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

Requalification

  • 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:

Background/experience

  • 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

Specific job skills

  • 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

Competencies

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

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