Investigation & Client Quality Specialist

Thermo Fisher Scientific seeks a quality assurance specialist to ensure compliance with GMP standards and regulatory requirements in a pharmaceutical or medical device environment. The role involves quality investigations, documentation review, and cross-functional collaboration to maintain product quality and drive continuous improvement.

Responsibilities

• Execute quality standards and ensure regulatory compliance in GMP environment
• Review and assess batch records, SOPs, and quality documentation for accuracy
• Conduct internal quality audits and support external regulatory audits
• Investigate quality deviations and implement corrective and preventive actions
• Collaborate with cross-functional teams to drive continuous improvement initiatives

Requirements

• Bachelor's degree in Chemistry, Biology, Biotechnology, Engineering, or related field
• Experience in pharmaceutical sterile, medical device, or regulated industry
• Strong knowledge of cGMP, ISO 13485/9001, and international regulatory requirements
• Proficiency with quality management software systems such as TrackWise or SAP
• Fluency in Italian and English, written and verbal
• Experience with quality systems documentation, batch records, SOPs, deviations, and CAPA
• Demonstrated ability to perform root cause analysis and quality investigations