Quality Compliance Specialist

2 giorni fa

Latina, Italia Hays A tempo pieno

🌟 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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