21 set - Bardi
UPS
Descrizione Impiego
Location: Somaglia (Lodi) (on site, with flexibility)
Contract: permanent
Working hours: standard
The Healthcare Quality Assurance Project Lead South Cluster is responsible for coordinating and supporting quality assurance activities across healthcare projects, ensuring the effective implementation and maintenance of the Quality Management System in compliance with ISO ****, ISO *****, EU GMP, and EU GDP requirements.
The role provides quality and compliance oversight for new buildings, client implementations, equipment, processes, audits, validations, risk assessments, change controls, and process improvement initiatives, while collaborating closely with internal stakeholders and external partners to ensure robust, compliant, and efficient project delivery.
Responsibilities
Coordinate the implementation and the maintenance of the Quality Management System (QMS) in accordance with ISO: **** and ISO: ***** 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
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: **** and/or ISO: ***** 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.
Tipo Di Dipendente
A tempo indeterminato
UPS si impegna a fornire un luogo di lavoro privo di discriminazioni, molestie e ritorsioni.
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