JUNIOR CONSULTANT COMPUTER SYSTEM VALIDATION | Ι2Β
Are you passioned about the Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise?
Junior Consultant Computer System Validation — Athens (f/m)
JOB DESCRIPTION
As Junior Computer Validation Specialist you will be supporting CSV projects in an international environ- ment. You will join projects or programs as Validation Lead Support and play a key role for our various customers in the pharmaceutical and medical technology industries. Your place of work is primarily at our customers‘ locations or remote, while our office in Athens (Greece) serve as central offices.
YOUR KEY RESPONSIBILITIES WILL BE.
- Act as a CSV consultant in various IT GxP projects for customers mainly in the Pharma industry
- Author and review deliverables according to customer QMS as well as the regulatory requirements
- Support requirements collection process to specify the processes
- Support risk assessment sessions to help identify risks associated to an IT system and support/
- monitor execution of associated mitigations
- Support testing activities by writing test specifications, executing and reviewing test cases as well as
- identifying issues in the documentation
- Support internal training activities and prepare material
- Support change management activities
- Support implementation of new tools
- Interact with project stakeholders on CSV topics
- Actively participate and encourage the development of profound strategic relationships with our
- project partners and contribute to the expansion of our customer network
QUALIFICATION AND EXPERIENCE.
- Background and/ or experience in Information Technology, Life Sciences
- Analytical Skills and good knowledge of MS Work, Excel, PowerPoint
- Practical work experience in regulated industries and Computer System Validation is a nice to have
- e.g. Pharma, Medical Devices or Laboratories
- Exposure to Software Quality Management, Software Testing and agile frameworks would be helpful
- Knowledge of standards such as 21 CFR 820, 21 CFR Part 11, ISO 14971 is a plus
- Very good command of writing and speaking English
- Good communication and presentation skills in English
- Strong interpersonal skills, proactivity and enthusiasm
- Flexibility, mobility and curiosity to learn
WE OFFER.
- Competitive compensation packages
- Comprehensive training programs
- A stimulating and multinational working environment
- Opportunities to work abroad
- Career advancement opportunities
- Group Health Insurance
- Business mobile phone
CONTACT DETAILS
Please send your meaningful CV and motivation letter in English to career@aueb.gr.
