Validation Officer
Found in: beBee S ZA - 4 weeks ago
Job title : Validation Officer (Port Elizabeth) jobs in Eastern Cape
Job Location : Eastern Cape, Pretoria
Deadline : May 04, 2024
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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.Requirements
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 experienceSpecific 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*Administrative / Management jobs in south africa
*Validation Officer (Port Elizabeth) in Pretoria
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