Validation Project Manager - Medical Devices - Solothurn

Vor Ort
6 months+
Templeton and Partners
flag_no Schweiz

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Validation Project Manager - Medical Devices - Solothurn, Switzerland


Higher education (Engineer or similar) and background in IT and at least 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

Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.

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 client Software Development Lifecycle as outlined in client 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.)