Internship Computerised System Validation & Quality Assurance

Siena, Italy

MAASI Enterprises is currently looking for final-year students (or those with only a few exams remaining) and recent graduates who are interested in undertaking a non-curricular internship in the following areas:

  • Computerised System Validation (CSV)
  • Quality Assurance (QA)
  • Regulatory Affairs
  • Process and System Validation
  • Approach to the Regulated Environment: 
    • GAMP5 
    • GxP

We particularly encourage applications from candidates with an academic background in:

Pharmaceutical Chemistry and Technology (CTF), Biotechnology, Engineering, Pharmaceutical Industry Management and Marketing, or other courses related to the field of Quality Assurance.

At the end of the internship, there is the opportunity for placement within our client organisations across Italy.

We are also open to considering candidates interested in developing skills in other technology-focused areas such as:

 🔸 Infrastructure & System Integration

🔸 System Engineering

🔸 Data Science

🔸 Machine Learning, Deep Learning, and Artificial Intelligence (AI)


Minimum Seniority
Technical 
Commercial 
Quality Assurance
Administration

During the internship you will learn to:

    • Definition and preparation of Validation Plans, Validation Reports, Test Plans, Acceptance Criteria, and User Requirements.
    • Management of Change Control processes and execution of Periodic Reviews.
    • Planning and execution of Data Integrity Assessments.
    • Authoring and reviewing Standard Operating Procedures (SOPs) and Work Instructions.
    • Preparation and maintenance of Technical Specification documents (Design Specifications and Functional Specifications), including revision control and approval workflows.
    • Authoring, reviewing, and executing FAT/SAT protocols for computerised systems, processes, and equipment.
    • Authoring, reviewing, and executing IQ, OQ, and PQ protocols for computerised systems, manufacturing processes, equipment, and utilities.
    • Execution and documentation of technical Impact Assessments.
    • Development and review of Calibration and Maintenance Plans.
    • Preparation and execution of qualification plans, test protocols, and procedures for IT and OT infrastructure.

Essential requirements:

  • Undergraduates or recent graduates
  • Passion and curiosity for the IT world
  • Knowledge of collaboration platforms (e.g., MS Teams, MS Outlook, Google Mail) and productivity tools (e.g., MS Office, Google Documents)
  • Good interpersonal and communication skills
  • Aptitude for problem solving and independent learning
  • Good knowledge of the English language (at least B2)
  • Ability to work in a team and independently

Position details


  • Main location: Siena 
  • Travel: NO   
  • ​Employment type: Internship
  • Hours of work: Monday to Friday, 39 hour/w
  • Salary range: paid Internship

What We Offer


  • Paid internship
  • Ticket lunch
  • Opportunity to work with one of the leading companies in pharmaceutical and Life Science consulting


MAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life. 

We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.



Rewarding  

A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.  

Trainings

Internal and external trainings specifically selected on your aptitudes and talent.

Welfare plan

A set of benefits, services and affiliations on top to the profession's health insurance.

we're Humans

We're a Company of human beings, before anything else. You'll never be "just a number" here.