Validation Officer

Found in: beBee S ZA - 4 weeks ago


Eastern Cape Pretoria, South Africa Aspen Pharma Group Full time
Aspen Pharma Group’s job vacancy, Career and Recruitment

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 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

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*Validation Officer (Port Elizabeth) in Pretoria


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