Overview

Validation Officer Job at Aspen Pharma Group – in Port Elizabeth, Eastern Cape

Job Description

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

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 (systems, cleaning

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

About Company

Company: Aspen Pharma Group –

Company Location:  Port Elizabeth, Eastern Cape

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About Aspen Pharma Group -