Quality Assurance Project Lead South Cluster

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Job Description:

Location: Somaglia (Lodi) (on site, with flexibility)

Contract: permanent

Working hours: standard

Please send CVs in English

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 9001, ISO 13485, 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: 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.

Employee Type:
 

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