Computerised System Validation Professional
7 giorni fa
We are seeking a skilled Computerised System Validation Specialist to join our team at Massimi Sistemi S.r.l. in Parma, Italy.
Key Responsibilities- Develop and execute validation plans, protocols, and reports for computer systems and processes.
- Provide client support in software system validation and manage change control processes.
- Conduct data integrity assessments and write standard operating procedures and work instructions.
- Draft design and functional specification documents and manage formal revision and approval processes.
- Perform technical impact assessments and write calibration and maintenance plans.
- Qualify IT/OT infrastructure and write review procedures.
- Strong knowledge of pharma standards and regulations, including ISPE GAMP and GxP, EUDRALEX, and FDA CFR 21.
- Proficiency in Italian and English languages, with CEFR C1 level or higher.
- Excellent professionalism and seriousness towards customers and colleagues.
- Internal and external training programs.
- Performance bonuses.
- Overtime pay in compliance with regulations.
- Team building activities.
Massimi Sistemi S.r.l. is committed to being an inclusive and equitable company, valuing differences and welcoming 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.
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