At Adiutum we strive to combine your balanced development with our growth and the customer’s satisfaction to ensure long term relationships.
ADIUTUM is looking for a Junior Validation Consultant
Your Responsibilities and Tasks
As a Junior Validation Consultant you will be involved in validation projects within an international pharmaceutical environment to ensure that every IT product, process or change have been properly evaluated before its utilization.
- Assess system’s documentation through the entire system lifecycle (validation plans, risk assessments, user requirements and functional specifications, test protocols, qualification phases)
- Ensure that system tests are successfully completed and documented and all problems are resolved following Good Automated Manufacturing Practice (GAMP) model and Financial (Sarbanes-Oxley - SOX) or Pharmaceutical (GxP, GCP, GMP, GLP) regulations
- Review and analyse a wide range of test plans, test scripts and quality control tests to ensure that computerized system meets specified standards (quality, security) and end-user requirements
- Provide trainings on system validation to end-users
- Support operational teams giving advice on quality controls and propose solutions aligned with applicable regulations and effective procedures
- Control system documentation for customer’s internal and external audits or inspections and assist the system owner during the audit activities
Your Skills and Knowledge
- Master’s degree in Bio-Engineering or Chemistry or Economics or Biomedical Engineering
- Analytical by nature with a passion for quality excellence and an eye for detail
- Excellent planning and organizational skills
- Report quickly and accurately (oral and written) in English and French
- Familiar with MS Office applications (Word, Excel, PowerPoint)
- Basic understanding of general information systems risks and controls
- Basic understanding of international Pharmaceutical (GMP/GCP/GLP) and/or Financial (Sarbanes-Oxley) regulations is a plus
- Familiar with IT validation model (e.g. V-Model) or with Quality Assurance processes is a plus
What's in it for you?
- We favour your development by helping you achieving certification tracks matching our business lines; you can grow towards consulting in Project management or Risk and Compliance management
- In addition, you will receive a competitive and attractive salary package along with many extra-legal advantages and a bonus plan
How to apply for this job?