QA Specialist

Amaris Consulting; Milano; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A technology consulting firm is seeking a QA Specialist to support quality assurance activities for clinical and commercial launches across EMEA. The ideal candidate has experience with cGMP requirements, clinical trial regulations, and a background in engineering or life sciences. This role offers a vibrant workplace with opportunities for professional growth and development in an international environment.

Servizi

Robust training system

Vibrant workplace with internal events

Strong commitments to CSR

Competenze

• Experience with deviation, change control, and audit management processes.
• Experience with clinical trial regulations.

Mansioni

• Support QA activities for clinical and commercial launches across EMEA.
• Coordinate planning and follow-up of supplier and site audits.
• Update and improve quality procedures and documentation.
• Follow-up investigations and deviations across clinical operations.

Conoscenze

Experience with cGMP / GTP requirements

Knowledge of CAR-T or advanced cell therapy

Fluent English

Ability to synthesize and communicate

Formazione

Academic background in engineering or life sciences

Strumenti

Document control systems (e.g., COMET, NC systems)

Descrizione del lavoro

Overview

• Who are we?
• Amaris Consulting
• is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
• Brief Call
• Our process typically begins with a brief virtual / phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
• Interviews
• the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
• Case study
• Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you!

Job description

• Join our team as
• QA Specialist
• full remote
• and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.

Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field, but above all being an ambassador of our organization to clients thanks to :

• Your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues.
• Your curiosity and eagerness to learn, as we support over 1000 clients from all sectors worldwide.
• Your missions
• Support QA activities for clinical and commercial launches across EMEA
• Coordinate planning and follow-up of supplier and site audits
• Update and improve quality procedures and documentation
• Follow-up investigations and deviations across clinical and commercial operations
• Provide QA input for Quality Agreements, Change Controls, and regulatory compliance
• Monitor cryogenic storage compliance, chain of custody and identity
• Provide technical QA support for third-party manufacturing and hospital centers
• Assess quality system maturity and drive improvement initiatives

Your profile

• Experience with cGMP / GTP requirements and clinical trial regulations
• Experience with deviation, change control, and audit management processes
• Knowledge of CAR-T or advanced cell therapy manufacturing is a strong asset
• Experience with document control systems (e.g., COMET, NC systems)
• Academic background: engineering or life sciences
• Fluent English. Other European language is a plus.
• You have an ability to synthesize and communicate complex quality and compliance topics clearly

What we offer

• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings etc.)
• Strong commitments to CSR notably through participation in our WeCare Together program