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Project Manager - CSV, Quality, Medical (German Speaker)
Eingestellt von Whitehall Resources Ltd
Gesuchte Skills: Support, Design
Projektbeschreibung
Project Manager - CSV, Quality, Medical required for a 9 months contract by my client in Solothurn, Switzerland.
Key Skills:
- Higher education (Engineer or similar) and background in IT
- Minimum 7 years work experience in project management.
- 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
- Excellent communication and cooperation skills.
Minimal language skills:
English & German fluent
Your role as a Project Manager:
- Strong knowledge of the Medical Device industry is required
- Experience in leading project teams is required
- The project manager 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
Computer System Validation:
- Planning and implementation of qualification/validation activities and projects of existing computer systems according to the client's Software Development Lifecycle as outlined in their 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
-These SDLC deliverables include:
Project Management (and all PM deliverables)
Detailed Design - Technical Design Spec
System Test script writing and execution/Application Installation Scripts
System Management Plan
Security Deliverables as required
BIA and Disaster Recovery Plan/Report (if applicable)
-Also possible to coordinate 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.).
For more details please contact Andreea Tomulescu
Key Skills:
- Higher education (Engineer or similar) and background in IT
- Minimum 7 years work experience in project management.
- 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
- Excellent communication and cooperation skills.
Minimal language skills:
English & German fluent
Your role as a Project Manager:
- Strong knowledge of the Medical Device industry is required
- Experience in leading project teams is required
- The project manager 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
Computer System Validation:
- Planning and implementation of qualification/validation activities and projects of existing computer systems according to the client's Software Development Lifecycle as outlined in their 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
-These SDLC deliverables include:
Project Management (and all PM deliverables)
Detailed Design - Technical Design Spec
System Test script writing and execution/Application Installation Scripts
System Management Plan
Security Deliverables as required
BIA and Disaster Recovery Plan/Report (if applicable)
-Also possible to coordinate 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.).
For more details please contact Andreea Tomulescu
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges