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Quality compliance specialist

Latina
Hays
Pubblicato il 12 dicembre
Descrizione

Pb Freelance Quality Compliance Specialist – Pharmaceutical Sector (Latina, Italy) /b /ppbLocation: /b Latina, Italy (100% On-site) /ppbWork Model: /b Full-time, Freelance Contract Available /ppbSector: /b Pharmaceutical Manufacturing /ppbLanguages Required: /b English Italian /ppbr/ppb Must be based in Italy – No sponsorship available /b /ppbr/ppWe are seeking a bQuality Compliance Specialist /b 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! /ppbr/ppb Key Responsibilities /b /pulliManage sterile process deviations, including writing and reviewing deviations and complaints. /liliOversee supplier qualification: manage certifications, review audit reports, and follow up on CAPAs. /liliReview bAnnual Product Reviews (APRs) /b and handle quality complaints, including investigations, reporting, CAPA definition, and follow-up. /liliIndependently manage the full complaint process, ensuring accurate impact assessments and effective communication across departments. /liliLead change control processes: evaluate, define activities with relevant teams, and monitor progress. /liliSupport production technologies with quality compliance: write/review APS protocols, PPQ batch records, and PPQ protocols/reports. /liliUtilize bTrackWise /b (preferred) for electronic quality management. /li /ulpbr/ppb Requirements /b /pullib2–5 years /b of specific experience in Quality Compliance within sterile pharmaceutical processes. /liliSolid knowledge of complaint management, CAPA processes, and change controls. /liliStrong background in supplier qualification and audit follow-up. /liliExperience with APS protocols, PPQ documentation, and production technologies. /liliFamiliarity with TrackWise or similar electronic quality management systems is a plus. /liliMust provide own PC. /liliFull-time availability: Monday to Friday, 08:30 – 17:00. /li /ulpbr/ppb /p /b

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