Computerised System Validation Specialist
We are looking for four Computer System Validation specialists with operational experience in the Life Sciences sector on behalf of our internationally renowned client.
- Independently managing the activities of test ideation and execution.
- Assisting the client in software system validation.
- Drafting validation plans, conducting tests, collecting and evaluating results, and preparing validation reports.
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.
- Execution 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.
**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.
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