Description
We are looking for a
Senior CSV Expert (Medical Devices) (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Place: im Bundesland Salzburg
Branch: Medizintechnik
Your tasks:
- Provide guidance, project management and reporting activities related to Computer Systems validation remediation activities
- Revise procedures related to the quality of the product or the quality system of the manufacturing
- Computer System Validation
- Planning and implementation of qualification / validation activities and projects of existing computer systems according to Software Development Lifecycle
- Support and consult 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 such as Project Management, Detailed Design - Technical Design Spec, Write and Run System Test Scripts / Application Installation Scripts, System Management Plan, Security Deliverables as required, BIA and Disaster Recovery Plan/Report (if applicable)
- Extended Duties: Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)
Your qualifications
- Higher education (Engineer or similar) and background in IT and Quality Systems
- Profound work experience in project management and previous experience as project leader
- Strong knowledge of the Medical Device manufacturing industry
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Important attributes are analytical, thorough, accurate and proficient in the use of computers
- 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 (spoken and written)
- Knowledge in technical skills like Technical Writing is requested
- Knowledge in MS Project is desired
Skills:
- Software developer
- Project manager
- Qualification/validation specialist