CSV Engineer (RE-33492736) Schwabenheim an der Selz
A gap assessment was performed at the Schwabenheim site to accommodate the transition from the current quality management system to the company standard called SDLC (System Development Lifecycle). The assessment found several steps that will need to be fulfilled to have the systems work and document on the company standard. An approved plan is in place to start. We need an CSV engineer/specialist to work on:
- Transition documentation to latest QMS versions
- Addressing gaps between current and to be documentation for comp. systems.
- Onsite coordination and communication on progress and activities
The individual will have a space to work and will use a company provided laptop to access the network and meet project goals (reviews, document generation, and executions).
The candidate must be able to speak English and German in order to work with both global specialists and the local maintenance and technical teams
Requirements for the candidate:
- Experienced with Computerized Systems Validation of Computerized Laboratory Systems and Spreadsheets;
- Familiar with the pharmaceutical industry;
- Familiar with GLP, GMP, 21 CFR Part 11, GAMP5;
- SDLC processes (System Development Lifecycle);
- Familiar with ITIL processes
- Good communicative properties (ENG);
- Good knowledge of IT configurations of Computerized Laboratory Systems and Spreadsheets.
zur Vakanz
Weitere Jobs von Aplitrak