Computerised System Validation Expert
4 giorni fa
We are seeking a highly skilled Computerised System Validation Specialist to join our team at Massimi Sistemi S.R.L. in Parma, Italy.
About the RoleThe ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically in CSV (Computerised System Validation), validation protocols, and Validation Plan, IQ/OQ/PQ processes.
Key Responsibilities- Independently manage the design and execution of tests.
- Provide client support in software system validation.
- Develop validation plans, conduct tests, collect and evaluate results, and prepare validation reports.
- Define and write Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
- Manage of Change Control and Periodic Review processes.
- Conducting Data Integrity Assessments.
- 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.
- 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).
- Utmost professionalism and seriousness towards customers and colleagues.
- Internal and external training programs.
- Performance bonuses.
- Overtime pay in compliance 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.
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