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Job Description
Location: Somaglia (Lodi) (on site, with flexibility)
Contract: permanent
Working hours: standard
Responsibilities
- Coordinate the implementation and the maintenance of the Quality Management System (QMS) in accordance with ISO: 9001 and ISO: 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.
- Applies his/her knowledge, skills and tools in assessing and supporting Projects from the quality and compliance point of view.
- Coordinate/execute various projects such as: Setting up the QMS in a new Building, Assessment of new Client opportunities, Implementation of new Clients, Implementation of new Equipment,

Implementation of new Processes,
- Supports External Audits within the scope of Project Management (e.g. new Client Audits, initial Regulatory Inspection).
- Conducts risk assessments on QMS processes to identify and mitigate any risks.
- Supports with process validation on new processes and new Buildings.
- Support and complete Design Qualification in a new Building and/or with new Clients.
- Keeps track of the projects, monitors the progress and identifies best practice and lessons learned.
- Coordinates process improvements projects within the applicable departments
- Create and provide training related to Client implementation
- Create Change Controls for any Projects where applicable

KEY INTERACTIONS
Internal :
- Project Management
- Operations Management
- QA Department / Document Control Department
- Solutions / Implementations
- Security
- BaSe Team
- Procurement Department
- V

Quality Assurance Project Lead South Cluster

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