CSV Engineer
Quanta Consultancy Services Ltd
CSV Engineer - Milan, Italy - 12 Month Contract
Our client is a leading global CDMO providing end‑to‑end pharmaceutical development and manufacturing services. Its expertise spans from APIs to finished drug products, supporting pharmaceutical and biotech companies in bringing medicines to market. With more than two and a half thousand employees worldwide, the organisation is driven by a mission to enhance patient lives.
Responsibilities
- Drafts and reviews validation documentation, including technical reports, for computerised system validations.
- Reviews SOPs, specifications, and production documents in compliance with GMP and company procedures.
- Reviews validation activities of computerised systems used in different departments, ensuring consistency with GMP requirements.
- Writes and reviews procedures related to computerised system validation.
- Supports, within the validation group, the operators performing tests to ensure computer system validation activities.
Qualifications
- High school diploma and/or degree in scientific subjects.
- Extensive experience in a similar role.
- Good knowledge of GMP.
- Good knowledge of English for documentation purposes and participation in customer and regulatory audits.
- IT knowledge relating to, for example: Client‑Server architectures, standalone systems, backup & restore, access and profile management, laboratory systems (LIMS; Empower), production systems (SCADA).
Offerta di lavoro pubblicata 3 giorni fa
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