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Deviations And Complaints Supervisor
3 settimane fa
Deviations and Complaints Supervisor We are looking for a Deviations and Complaints Supervisor who supervises and guides the management of quality deviations and complaints, identifies the main causes, and develops effective CAPAs, collaborates with business functions, ensures regulatory compliance, and contributes to the continuous improvement of the quality system. Key ResponsibilitiesSupervise the management of process, system, and product deviationsCoordinate the initiation, analysis, risk assessment, and closure of deviationsSupervise the management of quality complaints, including assessment of impact on product safety and efficacyEnsure compliance with timelines and regulatory requirements (GMP, GDP, EMA/FDA regulations)Approve root cause investigations (e.g., RCA, 5 Why, Fishbone)Ensure the definition, implementation, and verification of the effectiveness of CAPAsInterface with Production, Quality Control, Regulatory Affairs, and Supply ChainSupport internal and external inspections and audits, including regulatory authoritiesDraft and review procedures, reports, and trend analyses on deviations and complaintsMonitor trends, KPIs, and quality performance indicatorsRequired QualificationsDegree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biology, or related fields)Minimum of 7 years of experience in Quality Assurance within the pharmaceutical or biotech industryExcellent command of English, both written and spokenSoft SkillsLeadership and supervisory skillsAttention to detail and compliance-oriented mindsetAbility to work in regulated environmentsEffective communication and cross-functional collaborationDeviations and complaints supervisor • Milan, Lombardy, ITALYThis job posting is open to candidates of any gender, gender identity, and gender expression, in accordance with Italian Laws ****** and ******, and to candidates of all ages and backgrounds, in accordance with Legislative Decrees ****** and ******. By applying for this position, candidates authorize the processing of their personal data pursuant to Article 13 of Legislative Decree No. 196 of June 30, **** ("Personal Data Protection Code") and Article 13 of GDPR ****** ("EU General Data Protection Regulation").#J-*****-Ljbffr
