Computerised System Validation Specialist prov Ravenna Italy
Computerised System Validation Specialist prov Ravenna Italy
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Job Description
Computerised System Validation Specialist prov. Ravenna. Italy
Faenza Italy
We are looking forComputer System Validation specialist with operational experience in the Life Sciences sector on behalf of our internationally renowned client.
The ideal candidate will be responsible for:
- Independently managing the activities of test ideation and .
- Assisting the client in software system validation.
- Drafting validation plans conducting tests collecting and evaluating results and preparing validation reports.
For mid and senior roles ideal candidates must have proven experience as a consultant in the pharmaceutical and/or biotech industry.
Minimum Seniority
Technical
Commercial
Quality Assurance
Administration
Position details
- Main location:Prov. Imola
- Employment type:Permanent Contract
- Hours of work: Monday to Friday 9 am to 6 pm
- Reporting to: Project leader
- Salary range: Depending on skills and experience
Main Responsibilities
- Definition and drafting of Validation Plans Validation Reports Test Plans Acceptance Criteria User Requirements etc.
- Writing and reviewing Standard Operating Procedures and work instructions.
- Preparation of Technical Specification documents (Design and Functional) in collaboration with process or solution engineers and management of revisions and approval workflows.
- Writing and executing IQ/OQ/PQ test protocols for computerised systems processes equipment and utilities.
- of technical Impact Assessments.
- Writing and reviewing calibration and maintenance Plans.
- Writing and reviewing plans tests and procedures related to the qualification of IT/OT infrastructures.
- Definition and drafting of Validation Plans Validation Reports Test Plans Acceptance Criteria User Requirements etc.
Essential requirements
- High level of knowledge of pharmaceutical industry standards and regulations (ISPE GAMP and GxP EUDRALEX FDA CFR 21 etc).
- Excellent verbal and written communication skills: Italian and English at CEFR C1 level or higher (reading writing and speaking the interview will be conducted in both languages).
- Utmost professionalism and seriousness ability to maintain a distinguished and formal approach towards clients and colleagues.
- Excellent technical and communication skills and a strong motivation.
What We Offer
- Great career development opportunities.
- Internal and external training programs.
- Performance bonuses.
- Comprehensive welfare package.
- Meal vouchers.
- Overtime pay in accordance with regulations.
- Team building activities.
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 professions health insurance.
were Humans
Were a Company of human beings before anything else. Youll never be just a number here.
Required Experience:
Unclear Seniority
Employment Type
Full Time
