Leads global quality and environmental audits against ISO 9001 and ISO 14001, partnering with country teams to improve compliance, develop processes and tools, and raise service standards across branches.
Quality Assurance Engineer (Batch Record and Change Control)
📜 Description
- Support the transition from paper Batch Records to Electronic Batch Records (eBR).
- Issue, manage, and follow up on Change Controls with Production, QA, Engineering, Validation, and other functions.
- Support GMP documentation compliance activities.
🛠️ Requirements
- 2–3 years of experience in a GMP pharmaceutical environment.
- Experience with production documentation and/or Change Control.
- Good knowledge of GMP regulations.
- Excellent written and spoken English.
- Good interpersonal and teamwork skills.
- Availability for travel in Italy and abroad if required.
- Write, review, and manage Master Batch Records.
Full job description
- Scrittura, revisione e gestione dei Master Batch Record.
- Supporto al progetto di transizione da Batch Record cartaceo a Electronic Batch Record (eBR).
- Emissione, gestione e follow-up dei Change Control, coordinandosi con le diverse funzioni aziendali (Produzione, QA, Engineering, Validation, ecc.).
- Supporto alle attività di compliance documentale secondo GMP.
- 2–3 anni di esperienza in contesto farmaceutico GMP.
- Esperienza nella gestione documentale di produzione e/o Change Control.
- Buona conoscenza delle normative GMP.
- Ottima conoscenza della lingua inglese (scritta e parlata).
The compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.
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