Job Description

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

Validation Officer - 5 months Contract

The main purpose of the Validation Officer position is to prepare, plan, co-ordinate and execute all site validation activities and ensure compliance with SAHPRA/cGMP/PICS and corporate guidelines.

The position involves the following key responsibilities:

• 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

• 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

Fresenius Kabi