Fresenius is a globally active health care group providing products and services for dialysis, hospitals and the medical care of patients at home. In addition, Fresenius focuses on clinic operations as well as on engineering and services for hospitals and other health care facilities. Why work for Fresenius? You spend a significant part of your life in the w...
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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