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VALIDATION OFFICER

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Overview

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

 

Job requirements: 

Responsibilities

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

 

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 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

 

Competencies

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

Reference Number: 

ValidOfficer

Company: 

Aspen Pharma Group

City: 

Port Elizabeth

Country: 

ZA

Salary: 

Market Related

Job Type: 

fulltime

Industry: 

Pharmaceutical And Medical/Healthcare

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