Beschreibung
For a 9 month project we are looking ASAP for a Project Manager, in Italian-speaking Switzerland
Tasks:
Strong knowledge of the Medical Device industry is required. The consultant 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 computersKnowledge 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 J&J Software Development Lifecycle as outlined in Synthes Procedures. Support and consulting during projects handling GxP critical computer systems. Prepare and approve specific computer system validation documentation. CSV remediation activities to be conducted in cooperation with a QA CSV lead. Knowledge in technical skills like Technical Writing is requested.
Further tasks: Project Management, Requirements Identification and documentation, Detailed Design - Technical Design Spec, 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). 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 Familiarity with med. device manufacturing plants, SDLC (prefer J&J but can be flex). Minimal language skills: English & Italian fluent- both are essential for this position. Are you interested in this position? Then we are looking forward to receiving your application.
