Validation Officer
2 weeks ago
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- Job by industries
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
Requirements
- A Life Science or Chemical 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
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
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