Beschreibung
You are an outstanding Engineer with experience in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Starting date: ASAP
Duration: 9 months
Location: Oberdorf
Duties & Responsibilities:
- Computer Systems validation activities
- Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to company's internal and external requirements for all departments
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Creating specific computer system validation documentation
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Planning and implementation of qualification/validation activities and projects of existing computer systems according to Software Development Lifecycle
- Performing CSV trainings
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)
Requirements:
- Higher education (Engineer or similar) and background in IT and at least 3 years work experience
- Responsibility in similar position or extended experience as executer required. Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Experience in CSV system development life cycle is required
- Background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing
- Validation experience with ERP, MES, LIMS, and Quality Systems is preferred
- Languages: fluent English and German
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.