Computerised System Validation Specialist
We are looking to expand our Advisory and Consultancy division with several CSV (Computer System Validation) specialists with expertise in the Life Science industry.
The ideal candidate will:
autonomously manage the activities of designing and performing tests.
support the client in validating the software system
develop validation plans, perform tests, collect and evaluate results, and draft validation reports.
For the mid and senior role, you'll have proven experience as a consultant in the pharmaceutical and/or biotech industries.
Responsibilities
- Defining and writing Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
- Writing and reviewing Standard Operating Procedures and Work Instructions.
- Drafting of Design and Functional Specification documents in cooperation with our System or Process Engineers and managing formal revision and approval processes.
- Writing and executing IQ/OQ/PQ test protocols for computer systems, processes, equipment and utilities.
- Performing Technical Impact Assessments.
- Writing and reviewing Calibration and Maintenance Plans.
- IT/OT Infrastructure Qualification plan, tests and procedures writing and review.
Must Have
- Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
- Language skills: Italian and English CEFR C1 level or higher (read, written and spoken – the interview will be held in both languages).
- Utmost professionalism and seriousness towards customers and colleagues.
- Great technical and communication skills and a strong motivation.
Position details
- Primary job locations: Bologna e Faenza, Italy (4 vacancies: 1 Senior, 3 Jounior/Mid).
- Travel: n.a.
- Type: Full time
- Reports to: Project leader
- Level and salary: Depending on the actual experience achieved + bonus, training and welfare plan (backgrounds and expertise will be assessed).
What We Offer
Broad career development opportunities
Internal and external training programs
Performance bonuses
Comprehensive welfare package
Meal vouchers
Overtime pay in compliance with regulations
Team building activities
MAASI Enterprises aims to be an inclusive and fair company that welcomes and values individual differences. We believe in equal opportunities for all and apply fair working conditions and salaries that are commensurate with 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.