Overview

Experteer Overview In this role, you ensure product quality and regulatory compliance within a GMP environment, enabling scientific teams to perform breakthrough work. You’ll support continuous improvement and collaborate with cross‑functional partners to uphold high quality standards. The position combines audit activity, documentation review, and issue resolution to drive reliable, compliant operations. This is a mission‑driven opportunity to contribute to safer, healthier outcomes at scale. You will engage with audits, CAPA processes, and quality investigations to shape robust quality systems.

Responsibilities

- Ensure product quality and regulatory compliance in a GMP environment
- Drive continuous improvement initiatives and support quality initiatives across functions
- Collaborate with cross‑functional teams to maintain high standards of quality and compliance
- Perform internal quality audits and support external regulatory audits
- Review batch records, SOPs, deviations and CAPA documentation
- Conduct quality investigations and root cause analyses
- Maintain and utilize quality management systems and documentation
- Prepare and analyze documentation for audits and compliance




- Proactively identify quality risks and implement mitigation plans
- Utilize computer tools (TrackWise, SAP) and MS Office to manage records

Qualifications

- Bachelor’s degree
- Experience in pharmaceutical, medical device or regulated industry preferred
- Strong knowledge of cGMP, ISO 13485/9001, and international regulatory requirements
- Experience with quality systems and documentation (batch records, SOPs, deviations, CAPA)
- Proficiency with quality management software (TrackWise, SAP)
- Ability to perform detailed documentation reviews and quality assessments
- Strong analytical and problem‑solving skills for investigations and root cause analysis
- Excellent written and verbal communication skills
- Ability to work independently and in cross‑functional teams
- Experience with internal quality audits and supporting external regulatory audits
- Proficient in Microsoft Office
- Good attention to detail and accuracy
- Ability to prioritize and adapt in a changing environment
- Lean and Six Sigma experience preferred
- May require up to 10% travel
- Must be able to work in controlled environments wearing PPE

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📌 Investigation & Client Quality Specialist (Ferentino)
🏢 Experteer Italy
📍 Ferentino