We’re looking for a detail-oriented Quality Specialist to manage SOPs and Sponsor documentation, support quality systems and supplier qualification activities, deliver Sponsor quality services, and monitor KPIs/KQIs to ensure compliance and quality objectives are met.
Key Responsibilities:
- Manage SOPs, controlled documents, and Sponsor quality documentation within the QMS.
- Conduct compliance reviews of study documentation, systems, and training records.
- Provide GCP/GxP quality support and escalate compliance issues as needed.
- Support CAPA management, audits, inspections, and audit readiness activities.
- Perform vendor, site, and study audits, and manage supplier qualification processes.
- Support quality services, risk assessments, and maintenance of GCP/GxP and ISO-certified quality systems.
- Coordinate quality training and monitor quality metrics (KPIs/KQIs) to drive continuous improvement.
- Ensure timely completion of training, documentation, and administrative requirements.
- Perform additional quality and compliance-related duties as assigned.
Requirements:
- Bachelor’s degree, preferably in Life Sciences or a related scientific field.
- Strong English communication skills.
- Proficiency in Microsoft Office applications.
- Excellent planning, organizational, and time-management skills.
- Strong interpersonal skills with the ability to work collaboratively in a cross-functional team environment.
What we offer:
- Salary up to EUR 25,000/Anually
- Collaborative international environment
- Opportunity to work on impactful clinical research projects
- Professional growth and continuous learning
- Dynamic role combining technology and healthcare innovation
Who we are
OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and var
📌 Quality Specialist (Italia)
🏢 Opis
📍 Italia