Quality Assurance Project Lead South Cluster

United Parcel Service Sweden Aktiebolag; Lodi, Milano; Vor Ort; EUR 52.000 - 76.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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

Kenntnisse

Quality Assurance

Project Management

ISO 9001

ISO 13485

GMP/GDP

Root Cause Analysis

Documentation

MS Office

English

Italian

Spanish

Ausbildung

Bachelor's degree in Sciences

Tools

Quality Management System

Jobbeschreibung

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow-people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.

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
• Validation Department
• IT/ FUR Department

External :

• Regulatory Agencies
• Clients
• Suppliers
• Third Party Auditors

QUALIFICATIONS

Education level

• Bachelor's degree or International equivalent in Sciences- Required

Pharmaceutical, healthcare or food industry experience - Preferred

Quality Assurance experience - Preferred

Specialized Knowledge

• Proven experience in managing ISO: 9001 and/or ISO: 13485 standards
• Proven experience with GMP and/ or GDP guidelines is an advantage.
• Experience with Supply Chain Industry is an advantage.
• Experience with Root Cause Analysis tools (e.g. 5 why's, FMEA) is a must.
• Experience with Project Management is a must.

Skills

• Proficient in written and verbal English.
• Proficient in written and verbal Italian.
• Knowledge of Spanish is a plus.
• Strong verbal and written communication skills, to present recommendations and report back to different levels within the organization.
• Preferably experience in technical writing of documentation.
• Proficiency in Microsoft Office (MS Word, Power Point, and Excel).
• Knowledge of electronic Quality Management System is an advantage.
• Ability to prioritize decisions which may have a significant risk for the company.
• Ability to create networks and collaborate with various internal and external teams.
• Identify potential gaps in the processes and make recommendations for possible improvements.
• Coordination of improvement projects where needed.
• Implementation of new processes having a quality critical impact on the business.
• Recommend training opportunities.
• Strong organization, time management and planning skills.
• Flexible in working hours.

Employer Statement

UPS is committed to a policy of treating individuals fairly and recruiting, selecting, training, promoting and compensating based on merit, experience and other work-related criteria. We do not discriminate against any applicant based on age, race, religion, sex, disability, sexual orientation or gender identity.

Employee Type

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.