Quality Compliance Specialist
Descrizione dell'offerta
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.