Quality Operations Coordinator

Takeda; Santa Rufina; In loco; EUR 31.000 - 43.000; Tempo pieno

Descrizione del lavoro

Takeda Italia cerca un professionista QA per garantire la conformità GMP, definire e mantenere la collaborazione tra Quality e Production e supervisionare la revisione delle batch record.

Richiesta Laurea in disciplina scientifica, eccellente conoscenza dell'inglese e padronanza delle normative GMP. Il ruolo comporta gestione di CAPA, gestione eventi e miglioramento dei processi in un contesto di produzione.

Competenze

• Laurea in disciplina scientifica o equivalente e conoscenza delle normative regolatorie.
• Buona padronanza dell'inglese scritto e parlato.
• Ottima conoscenza del processo di produzione e principi della qualità.
• Esperienza o comprensione di GxP e gestione CAPA.

Mansioni

• Revisione batch record conforme a SOP e normative.
• Gestione eventi individuati durante la revisione o segnalati dalla produzione.
• Riesame procedure di produzione e master batch record.
• Identificazione di opportunità di miglioramento e implementazione CAPA.
• Collaborare con la Produzione per chiudere gap di conformità.
• Guidare progetti di sviluppo per approfondire attività di produzione.
• Gestione documentazione GMP, archiviazione, raccolta dati e distruzione.
• Preparare campioni di pulizia attrezzature.
• Verificare conformità requisiti di ricezione plasma.

Conoscenze

Laurea in disciplina scientifica

Buona conoscenza dell'inglese

Conoscenza GMP/cGMP

Analisi e risoluzione problemi

Formazione

Laurea in disciplina scientifica

Descrizione del lavoro

Job Description

Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.

OBJECTIVES/PURPOSE

• Verifies and ensures compliance with GxP and site procedures, defining and maintaining collaboration between Quality and Production.
• Verifies and ensures product quality in accordance with regulatory requirements and standard operating procedures.
• Promotes and disseminates quality principles within the Production department.

ACCOUNTABILITIES

• Review and ensure the execution of quality batch record review in compliance with SOPs and regulations.
• Open and manage events identified during batch record review and/or reported by production operators.
• Review production procedures and master batch record.
• Identify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas.
• Actively collaborate with Production to identify and resolve compliance gaps, both documentation‑related and on the shop floor.
• Lead/execute development projects aimed at deepening knowledge of production activities.
• Ensure GMP documentation management, including archiving, data collection, and document destruction.
• Prepare equipment cleaning samples.
• Verify the compliance of plasma receipt requirements.

CORE ELEMENTS RELATED TO THIS ROLE

• ensuring batch record review, data integrity of production systems, and the management of events, changes, and CAPAs;
• collaborating with Production to resolve compliance gaps and ensure traceability and control of GMP documentation.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Required

• Degree in scientific discipline and knowledge of pharmaceutical applicable regulations, or demonstrated/approved knowledge of manufacturing processes.
• Good command of English.
• Excellent knowledge of the manufacturing process and quality principles.

Leadership

• Be positive
• Be accountable
• Be results-oriented
• Good communication skills
• Problem-solving attitude
• Good teamwork skills
• Good knowledge of cGMP

Decision-making and Autonomy

• Good ability to work independently

Interaction

• Good communication and negotiation skills

Innovation

• Good ability to optimize workflows in classified areas

Complexity

• Direct interface with Production, Maintenance, Calibration, and Quality personnel

Education, behavioural competencies and skills

• Good command of English (written and spoken)
• Excellent analytical and problem-solving skills
• Excellent communication, negotiation, and leadership skills
• Excellent technical writing skills and presentation skills.

Locations

ITA - Rieti

Base Salary Range

€31,200.00 - €42,900.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time