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Quality compliance specialist

Latina
Hays
Pubblicato il 12 dicembre
Descrizione

Freelance Quality Compliance Specialist – Pharmaceutical Sector (Latina, Italy)Location: Latina, Italy (100% On-site) Work Model: Full-time, Freelance Contract Available Sector: Pharmaceutical Manufacturing Languages Required: English & Italian Must be based in Italy – No sponsorship availableWe are seeking a Quality Compliance Specialist with hands-on experience in sterile process management to support a leading pharmaceutical company in Latina. This is a fantastic opportunity for professionals looking to contribute their expertise in a dynamic, compliance-driven environment. Freelancers are welcome to apply! Key ResponsibilitiesManage sterile process deviations, including writing and reviewing deviations and complaints.Oversee supplier qualification: manage certifications, review audit reports, and follow up on CAPAs.Review Annual Product Reviews (APRs) and handle quality complaints, including investigations, reporting, CAPA definition, and follow-up.Independently manage the full complaint process, ensuring accurate impact assessments and effective communication across departments.Lead change control processes: evaluate, define activities with relevant teams, and monitor progress.Support production technologies with quality compliance: write/review APS protocols, PPQ batch records, and PPQ protocols/reports.Utilize TrackWise (preferred) for electronic quality management. Requirements2–5 years of specific experience in Quality Compliance within sterile pharmaceutical processes.Solid knowledge of complaint management, CAPA processes, and change controls.Strong background in supplier qualification and audit follow-up.Experience with APS protocols, PPQ documentation, and production technologies.Familiarity with TrackWise or similar electronic quality management systems is a plus.Must provide own PC.Full-time availability: Monday to Friday, 08:30 – 17:00.

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