Beschreibung
For our client in Mezzovico we are looking for a Calibration Specialist (Computer System Validation) for a 3 month contract.
Duration: 15.01.2018-09.03.2018
Workload: 80%
Place: Mezzovico
Tasks
- Calibration of MAHR Machine
- Computer Systems validation
- Implementation of qualification/validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within the company.
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Computer systems according to the Software Development Lifecycle
- Performing CSV trainings
Extended Duties: 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 5 years work experience
- Responsility 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 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.
- CSV Experiences ca. 5 years
- Calibration Experience 3 years
Language requirements: Italian and English spoken and written
For more information, please contact: Anna Chmura (see below)