Validation Officer - Port Elizabeth at Fresenius Group

General Duties:

•  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
• Control of delegated Validation Plans
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• A Life Science or Chemical Engineering degree or equivalent
• 3-5 years of validation experience within the pharmaceutical manufacturing industry
• Knowledge of production processes
• Systems, product, industry and equipment knowledge
• Use of statistical techniques
• Knowledge of analytical, technical and engineering methods

Competency requirements are as follows:

• Attention to detail
• Time Management
• Planning skills; Problem solving
• Organizational skills; communication Skills
• Protocol and technical report writing skills and Computer literacy