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Deviations and complaints supervisor

Liscate
Avara Pharmaceutical Services
Pubblicato il 21 gennaio
Descrizione

PWe are looking for a strongDeviations and Complaints Supervisor /strong 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. /ppbr/ppstrongKey Responsibilities /strong /pulliSupervise the management of process, system, and product deviations /liliCoordinate the initiation, analysis, risk assessment, and closure of deviations /liliSupervise the management of quality complaints, including assessment of impact on product safety and efficacy /liliEnsure compliance with timelines and regulatory requirements (GMP, GDP, EMA/FDA regulations) /liliApprove root cause investigations (e.g., RCA, 5 Why, Fishbone) /liliEnsure the definition, implementation, and verification of the effectiveness of CAPAs /liliInterface with Production, Quality Control, Regulatory Affairs, and Supply Chain /liliSupport internal and external inspections and audits, including regulatory authorities /liliDraft and review procedures, reports, and trend analyses on deviations and complaints /liliMonitor trends, KPIs, and quality performance indicators /li /ulpbr/ppstrongRequired Qualifications /strong /ppDegree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biology, or related fields) /ppbr/ppstrongTechnical Skills /strong /pulliMinimum of 7 years of experience in Quality Assurance within the pharmaceutical or biotech industry /liliExcellent command of English, both written and spoken /li /ulpbr/ppstrongSoft Skills /strong /pulliLeadership and supervisory skills /liliAttention to detail and compliance-oriented mindset /liliAbility to work in regulated environments /liliEffective communication and cross-functional collaboration /li /ulpbr/ppbr/ppemThis job posting is open to candidates of any gender, gender identity, and gender expression, in accordance with Italian Laws 903/77 and 125/91, and to candidates of all ages and backgrounds, in accordance with Legislative Decrees 215/03 and 216/03. /em /ppemBy applying for this position, candidates authorize the processing of their personal data pursuant to Article 13 of Legislative Decree No. 196 of June 30, 2003 (“Personal Data Protection Code”) and Article 13 of GDPR 679/16 (“EU General Data Protection Regulation”). /em /p

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