QA Project Lead – Quality Systems & Compliance

United Parcel Service Sweden Aktiebolag; Lodi, Milano; On-site; EUR 52,000 - 76,000; Full time

Job summary

UPS is seeking a Quality Assurance/Project Manager to coordinate the QMS in Somaglia (Lodi), Italy on site with flexibility. This permanent role involves standard working hours and close collaboration with multiple departments.

You will drive ISO 9001 and ISO 13485 compliance, support audits, conduct risk assessments and participate in process validations for new processes, buildings and client implementations. Fluent English and Italian are required; Spanish is a plus.

Qualifications

• Bachelor's degree or international equivalent in sciences (required).
• Pharmaceutical, healthcare or food industry experience - preferred
• Quality Assurance experience - preferred

Responsibilities

• Coordinate the implementation and maintenance of the QMS in accordance with ISO: 9001 and ISO: 13485 standards, and in compliance with EU GMP and GDP guidelines.
• Applies knowledge, skills and tools in assessing and supporting Projects from the quality and compliance point of view.
• Coordinate/execute projects such as setting up the QMS in a new Building, assessment of new Client opportunities, implementation of new Clients, equipment, and processes.
• Support External Audits within the scope of Project Management (e.g. new Client Audits, regulatory inspections).
• Conduct risk assessments on QMS processes to identify and mitigate risks.
• Support with process validation on new processes and new Buildings.
• Support and complete Design Qualification in a new Building and/or with new Clients.
• Keep track of the projects, monitor progress and identify best practices and lessons learned.
• Coordinate improvement projects within applicable departments.
• Create and provide training related to Client implementation.
• Create Change Controls for any Projects where applicable

Skills

Quality Assurance

Project Management

ISO 9001

ISO 13485

GMP/GDP

Root Cause Analysis

Documentation

MS Office

English

Italian

Spanish

Education

Bachelor's degree in Sciences

Tools

Quality Management System

Job description

UPS is seeking a Quality Assurance/Project Manager to coordinate the QMS in Somaglia (Lodi), Italy on site with flexibility. This permanent role involves standard working hours and close collaboration with multiple departments.

You will drive ISO 9001 and ISO 13485 compliance, support audits, conduct risk assessments and participate in process validations for new processes, buildings and client implementations. Fluent English and Italian are required; Spanish is a plus.