Project Manager - CSV, GXP, Quality Systems Manufacturing

REFERENCE: JNJ

ROLE: PROJECT MANAGER

SKILLS: CSV, GXP, Project Management, PMI, Medical Device, MS Projects

LOCATION: Switzerland, Raron CHE 3942

HOURS: Per day 8 hours, Hours per week 40, 6 month contract

EXTRA: English and German written and spoken

My client is looking for a Project Manager with a strong knowledge of the Medical Device industry is required.

You will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities

You must have a 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.

You will need:

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 J&J Software Development Lifecycle as outlined in Synthes Procedures.
- Support and consulting during projects handling GxP critical computer systems

Project Management (and all PM deliverables)

System Test script writing and execution/Application Installation Scripts

UAT Testing

System Management Plan

Writing of Work Instructions/Procedures

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.).

Requirements:

- 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

Minimal language skills:

English- Additional PMI certification is a plus; Language
- proficiencies: -English spoken and written;