Computerised System Validation Specialist
1 mese fa
As a Computerised System Validation Specialist at Massimi Sistemi S.R.L., you will be responsible for managing test ideation and execution, assisting clients in software system validation, and drafting validation plans, conducting tests, collecting and evaluating results, and preparing validation reports. This role requires proven experience as a consultant in the pharmaceutical and/or biotech industry. Your key responsibilities will include:
• Defining and drafting validation plans, validation reports, test plans, acceptance criteria, user requirements, and other related documents.
• Assisting in the preparation of technical specification documents in collaboration with process or solution engineers, and managing revisions and approval workflows.
• Executing IQ/OQ/PQ test protocols for computerised systems, processes, equipment, and utilities.
• Conducting technical impact assessments and writing/reviewing calibration and maintenance plans.
• Developing and executing plans, tests, and procedures related to the qualification of IT/OT infrastructures.
Requirements
• Strong knowledge of pharmaceutical industry standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
• Excellent verbal and written communication skills, with Italian and English proficiency at CEFR C1 level or higher.
• Ability to maintain a distinguished and formal approach towards clients and colleagues.
What We Offer
At Massimi Sistemi S.R.L., we offer a competitive salary package, a growth plan, and attractive bonuses based on results. You will also have access to internal and external training programs, performance bonuses, and overtime pay in accordance with regulations. We value diversity and promote equal opportunities for everyone.
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Ravenna, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov. Ravenna. ItalyWe are looking for four Computer System Validation specialists 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 execution.Assisting the...
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Ravenna, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov. Ravenna. Italy We are looking for four Computer System Validation specialists 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 execution.Assisting the...
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Ravenna, Italia Massimi Sistemi S.r.l. A tempo pienoComputerised System Validation Specialist, prov. Ravenna. Italy We are looking for four Computer System Validation specialists 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 execution. ...
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Ravenna, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov.Ravenna.Italy We are looking for four Computer System Validation specialists 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 execution.Assisting the...
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