Quality Compliance Specialist
2 giorni fa
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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