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South Africa

Validation Officer

Company Fresenius Kabi Manufacturing SA (Pty) Ltd
Reference # ValCj002
Published 19/05/2020
Contract Type Contract
12 Months
Salary Market Related
Location Port Elizabeth, Eastern Cape, South Africa
Introduction
•To prepare, plan, co-ordinate, execute all site validation activities
•To ensure the Validation Department for FKMSA Port Elizabeth facility complies with SAHPRA/cGMP/PICS and corporate guidelines
Job Functions Administration,Analysis,Compliance & Regulatory Affairs,Investigation & Compliance,Monitoring & Evaluation,Operations,Quality Control,Risk Analysis
Industries Chemical / Petrochemical,Engineering,Fmcg (Fast Moving Consumer Goods Sector),Food & Beverages,Manufacturing,Petrochemical,Pharmaceutical / Medical / Healthcare / Hygiene,Production,Regulatory
Specification
•Development of User Requirement Specifications
•Development of Manufacturing Procedures
•Qualification and re-qualification of equipment and utilities
•Development and execution of System Impact Assessments and Component Impact Assessments
•Development and execution of Validation Risk Assessments and Design Reviews
•Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
•Development and execution of Process Validation studies
•Validation of computerised systems validation
•Validation of Automated System
•Validation of sterilisation equipment and cycles
•Performance of Factory Acceptance Testing and Site Acceptance Testing
•Control of delegated Validation Plans

Requirements
A Life Science or Engineering degree or equivalent.
•3-5 years of experience of validation in the pharmaceutical industry
•Knowledge of production processes
•Systems, product, industry and equipment knowledge
•Use of statistical techniques
•Knowledge of Analytical, technical and Engineering methods
Job Closing Date 29/05/2020
   
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