Beschreibung
Aufgabe:- Planning and implementation of qualification / validation activities and projects of existing computer systems according to our customer´s Software Development Lifecycle as outlined in our customer´s 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 conducted in cooperation with a QA CSV lead
- support the IT deliverables for the CSV remediation
- These SDLC deliverables include:
- Project Management (and all PM deliverables)
- Detailed Design ? Technical Design Spec
- System Test script writing and running / Application Installation Scripts
- System Management Plan
- Security Deliverables as required
- BIA and Disaster Recovery Plan/Report (if applicable)
o will possibly be engaged in working with the migration of payroll and HR to our customer´s standards.
o Also possible to contribute to the infrastructure integration planning activities and possibly some of the execution based on timing.
- Extended Duties:
Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Anforderung:
- Strong knowledge of the Medical Device industry is required
- the consultant will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities
- The person must be analytical, thorough, accurate and proficient in the use of computers
- Knowledge in MS Project is desired.
- 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.
- Knowledge of regulation as defined by ISO and FDA is desired
- Knowledge in technical skills like Technical Writing is requested
Beginn: 28.04.2014
Dauer: 31.12.2014
Branche: Medizin/Healthcare