Beschreibung
Validation Specialist : - GxP / ISO 13458/CSV/Medical/ GermanRole Purpose: Our client is looking for an experienced Validation Specialist in Luzern location for a contract initially for 10 months with strong possibility of extension.
Main tasks:
- Independently responsible for the implementation and documentation of validation and qualification activities according to valid specifications and project planning, in close cooperation with internal and external partners/interfaces of Operations Instrumentation, in particular for the Instrumentation divisions and all custom-made systems of the Tech Support department.
-Responsible to write test plans for software that controls test sequences .
- Responsible for software validation, database connection, Excel
- Responsible for the qualification of custom-made test systems for use in the internal production environment.
- We are jointly responsible for ensuring compliance in accordance with the applicable internal specification documents.
- Review of validation/qualification documents, checking for formal and content correctness.
- Creation of validation/qualification plans and reports, as well as test plans/reports
- Planning and implementation of validation and qualification tasks, as well as maintenance of existing qualification documentation
- Qualification of equipment, such as standard equipment, custom-built systems or measuring equipment
- Responsible for the validation of test stations (custom-built, consisting of various subsystems incl software shares.
- Responsible for the validation of software and Excel workbooks in accordance with CSV (computerized system validation)
- Responsible for support and technical advice for operators and users of equipment and systems in the execution of validation and qualification tasks.
- Reporting, coordination and coordination of priorities with clients, partners/interfaces such as sub-project managers, product leaders, line managers and contact persons from the specialist departments.
- Cooperation in the preparation of risk analyses for equipment and systems.
Technical Skills Must Have:
- Good experience in the regulated GxP environment ideally of medical technology (ISO 13458, GMP, FDA 21 CFR 820)
- Good comprehension, recognition of complex interrelationships, pronounced quality awareness and a structured, systematic procedure.
- Should have very good understanding of complex processes in test processes and software functions
- Must have good communication skills, ensuring information flow, coordination of different stakeholders -High team skills, flexibility and resilience.
- Should be a good independent and responsible work in a diverse product and project environment.
- Must have good mathematical skills to independently calculate the formulas of the software in Excel using raw data, trens & correlations .
- Should have a high technical understanding of test/process sequences, and software functions for hardware/software architectures are prerequisites for writing software test plans using specifications.
Nice to Have :
- Must have good knowledge of IT (SAP, MS Office) and good knowledge of hardware and software architectures .
- Good experience working medical or pharma environment.
Education: Bachelor or Master university of applied sciences degree or equivalent education, specialising in technology, science or medical technology.
Languages:
- Fluent in English (Writtern & Oral).
- Fluent in German
Reference No.: 918271NC
Role: Validation Specialist
Domain: Medical
Location: Luzern und region, Switzerland
Workload: 100 %
Start Date: ASAP
Duration: Till
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us: ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.