Lavori attuali relativi a Computerised System Validation Expert - Parma, Emilia-Romagna - Data Rover
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Parma, Emilia-Romagna, Italia Adeodata A tempo pienoIntroduzioneAdeodata, con oltre 20 anni di esperienza nel settore Life Science, offre servizi di consulenza alle aziende del nostro gruppo. Con più di 100 dipendenti, Adeodata rappresenta un ambiente giovane e collaborativo dove ogni contributo è considerato fondamentale.Descrizione del ruoloIl candidato ricoprirà il ruolo di Tecnico di Validazione dei...
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Sterile Process Engineer
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Computerised System Validation Expert
2 mesi fa
We are seeking a highly skilled Computerised System Validation Specialist to join our team at Data Rover. As a key member of our Life Sciences sector, you will be responsible for ensuring the validation of computerised systems in the pharmaceutical and biotech industry.
Responsibilities- Independently manage the design and execution of tests for computerised systems.
- Provide client support in software system validation, including developing validation plans and conducting tests.
- Collect and evaluate results, and prepare validation reports to ensure compliance with pharma standards and regulations.
- Define and write validation plans, validation reports, test plans, acceptance tests, user requirements, and manage change control and periodic review processes.
- Conduct data integrity assessments and write and review standard operating procedures and work instructions.
- Draft design and functional specification documents in cooperation with system or process engineers and manage formal revision and approval processes.
- Write and execute IQ/OQ/PQ test protocols for computer systems, processes, equipment, and utilities, and perform technical impact assessments.
- Write and review calibration and maintenance plans, IT/OT infrastructure qualification plans, tests, and procedures.
- 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.
We value differences and welcome people from all walks of life. We believe in equal opportunities for everyone and apply fair working conditions and salaries related to assigned responsibilities, skills, and personal merit.
