Beschreibung
Task:- Planning and implementation of qualification / validation activities and projects of existing computer systems according to software development of our customer´s 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:
a) Project Management (and all PM deliverables)
b) Detailed Design ? Technical Design Spec
c) System Test script writing and running / Application Installation Scripts
d) System Management Plan
e) Security Deliverables as required
f) BIA and Disaster Recovery Plan/Report (if applicable)
- will possibly be engaged in working with the migration of payroll and HR to standards of our customer.
- 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.).
Requirements (Must have):
- Knowledge in technical skills like Technical Writing is requested
- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- 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.
Minimal language skills:
English & German fluent
Beginn: 01.12.2013
Dauer: 30.04.2014
Branche: Medizin/Healthcare