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Quality compliance specialist

Roma
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 available


We 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 Responsibilities

* Manage 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.


📌 Requirements

* 2–5 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.


🤝 What We Offer

* Opportunity to work with a well-known pharmaceutical company in Latina.
* Freelance contract option for independent professionals.
* Collaborative environment with cross-functional teams.
* Valuable experience in a highly regulated industry.


👉 If you’re a proactive professional with a passion for quality compliance in sterile pharmaceutical processes, we’d love to hear from you. Apply now and bring your expertise to a project that makes a real impact in healthcare!

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