Career
Why join us?
This is a question that may change your life, or even change our way of thinking as a company and employers. Here in i2b we take great pride in offering interesting and challenging workplace conditions for multiple job descriptions which can enable you to develop yourself as well as the entire organization. We understand that every person is unique and brings different experiences to the table, so why not have a look into our consultancy-leading contracts and job offers below and let i2b be your next step into the future.
Athens, GR
Job Description
As Junior Computer Validation Specialist you will be supporting CSV projects in an international environment. 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 CV and motivation letter in English to recruiting@i2b.ch for the attention of Katerina Chaletsou.
Tägerwilen, CH
job description
As Senior Computer Validation Specialist you independently perform CSV projects in an international environment. You support projects or programs as Validation, Computer Validation or Test Lead, you develop validation strategies, and play a key role for our various clients in the pharmaceutical and medical technology industries.
The ideal candidate will be able to demonstrate strong relationship management skills and will be able to handle challenging interpersonal situations.
The ideal candidate needs to be able to work as a CSV manager and independently run multiple simultaneous projects.
Additionally, the ideal candidate will need to demonstrate a successful track record of budget monitoring, tracking and reporting.
Lastly, the ideal person for this role will need be able to act as the single accountable person of running multiple, concurrent projects.
your key responsibilities will be
- Independent implementation of projects in the fields of IT / GxP Compliance, and Computer System Validation (CSV)
- Leading role in Quality /Compliance Management as part of national and international project teams - on-site at clients‘ locations from the Life Science Industry
- Managing role in validation of software-system projects, in accordance with regulatory compliance and through implementation of new tools - especially for SAP applications
- Execution of training and coaching in the areas of Computer System Validation (CSV), IT Compliance, and Test Management
- Integration, instruction, and management of our (Junior) Consultants during projects
- Development of strategic relationships with our project partners as a single point of contact
- Expansion of our customer network and support our established customer base
qualification and experience
- Bachelor degree in natural sciences, business administration, computer sciences or higher
- Professional experience in implementation of complex validation projects, IT Compliance /CSV (with relevant knowledge in regulatory compliance processes in the areas of GxP and / or medical technology)
- Professional Experience in the area of Compliance (e.g. IT Compliance, CAPA Management, Change or Release Management) and knowledge of standards (e.g. 21 CFR 820, 21 CFR Part 11, ISO 14971)
- Several years active as CS QA,CSV Lead or similar
- Interest in project acquisition
- Interest in building up a near shore team (Athens)
- Systematic approach and good analytical skills
- High level of proficiency of the English language for effective communication with our national and international projects
- Excellent analytical thinking and high abstraction capabilities, quick perception, strong persuasive skills and creative power
- Excellent customer focus, strong social and networking skills
- Strong interpersonal skills and high enthusiasm
- Flexibility and mobility
- Experience working across projects with complex process interfaces, globally distributed sites functions/sites, and overall high risk
-
Nice to Have Skills: knowledge in Serialization for Pharmaceuticals, Familiarity with SAP system and specific SAP CSV requirements
we offer
- Competitive compensation packagesComprehensive training programs
- A stimulating and multinational work environment
- Opportunities to work abroad
- Very good career advancement opportunities
- Group Health Insurance
- Business mobile
contact details
Please send your meaningful CV and motivation letter in English to to recruiting@i2b.ch for the attention to Björn Adams.Freelance Consultant
You are a freelance consultant with great experience in the Pharmaceutical, Biotech and Medical Device or Chemistry industry? You have good knowledge in SAP ERP/ Track &Trace or Computer System Validation concepts?
I2b has increasing requests to support international projects around the globe. We frequently require additional help in order to fulfill our customers needs. If you are a freelancer with deep knowledge and experience in the above listed areas, we would like you to register your CV in our Freelance Consultant database.Please send your meaningful CV and motivation letter in English to recruiting@i2b.ch