Beschreibung
Project Manager
Our client, a multi-national pharmaceutical company, are seeking a Project Manager to join their CSV (Computer System Validation) Team to provide guidance, project management and reporting activities related to CSV remediation activities
The Project Manager will be responsible for:
- Planning and implementation of qualification/validation activities and projects of existing computer systems according to Software Development Lifecycle as outlined in Procedures.
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- CSV remediation activities to be coordinated in cooperation with a QA CSV lead
- Support the IT deliverables for the CSV remediation
The ideal Project Manager will have the following skills and experience:
- Higher education (Engineer or similar) and background in IT and at least 7 years work experience in project management.
- 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.
- 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 CFRPart 820, Part 11
- Familiarity with med. device manufacturing plants, SDLC
- Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.
- Knowledge of regulation as defined by ISO and FDA is desired
This is a great opportunity to join a global organisation who pride themselves on providing a great working environment to attract, retain and develop talent.
If you are interested to learn more please email with an up to date CV and contact details