Beschreibung
Our client is currently looking for a Senior Computer System Validation (CSV) Consultant (m/f) Pharma for a project in Rheinsheim.Project Description:
- Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to Synthes internal and external requirements for all departments within Synthes EMEA
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation and acting as software quality assurance
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Performing CSV trainings
Qualifications:
- Experiences with Polarion is a must
- Responsibility in similar management position or extended experience as executer required
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820/Part 11
Required languages: good written and spoken English/ German
Location: Rheinsheim
Duration: 1.3.2016 - 30.6.16
Contact:
Jeannine Keith
If this is of interest to you, please send us your CV (incl. all necessary contact details [name, address, telephone numbers, Email]) referring to the project name and relevant contact person. Please refrain from sending several attachments. We would appreciate any information concerning your availability and rate expectations. We are looking forward to receiving your application.