06 ott - Lazio
Thermo Fisher Scientific
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 **********, 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
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