Posted on: 06 April 2024
ID 911591

Validation Officer

Job Purpose
  • 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
  • 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.
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
  • 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
#TL
Occupation:
Manufacturing jobs


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