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Quality on the Floor Specialist

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Junior Level
  • Milan

AI generated summary

  • You need a degree in CTF, Pharmacy, Chemistry, or Biology, 2+ years in QA/Production in pharma, shift availability, good English, and strong teamwork and interpersonal skills.
  • You will review GMP lots, monitor production activities, promote quality culture, train staff, collaborate on investigations, and ensure compliance with quality standards and regulations.

Requirements

  • Laurea in CTF, Farmacia, Chimica, Biologia, analoghe lauree a indirizzo scientifico.
  • Almeno 2 anni di esperienza in realtà farmaceutiche in ruoli all'interno dei Reparti QA o Produzione.
  • Disponibilità a lavorare su turni (7x3, ciclo continuo)
  • Buona conoscenza della lingua inglese.
  • Capacità di lavorare in team ed ottime doti relazionali.

Responsibilities

  • Effettua la revisione dei lotti GMP rilevanti e ne verifica la conformità alle specifiche, alle procedure aziendali ed alle normative vigenti dichiarandola mediante l’utilizzo dell’apposita check-list.
  • Effettua sorveglianze periodiche delle attività produttive e promuove la Quality Culture diffondendola pro-attivamente all’interno dei Reparti.
  • Incoraggia la condivisione delle problematiche e delle relative azioni correttive con il Reparto Produzione mediante huddle periodici.
  • Partecipa, in collaborazione con il Reparto Produzione e il Team PPI, al miglioramento continuo del Reparto, fornendo supporto nell’implementazione di nuovi flussi, nell’ottimizzazione di procedure o nella creazione di Tool PPI.
  • Esegue l’addestramento del personale coinvolto nella attività di Quality on the Floor e di quello operante nei Reparti per attività legate alla propria area di competenza, in accordo alle vigenti procedure aziendali.
  • Collabora con la funzione Quality Operations e con i Quality Specialist di Reparto al fine di assicurare la corretta esecuzione delle indagini, fornendo supporto per la comprensione delle cause e partecipando all’identificazione delle più idonee azioni correttive o preventive, in accordo agli standard qualitativi aziendali ed alle normative vigenti.
  • Opera nel rispetto degli standard di qualità aziendali, attraverso l’applicazione delle procedure relative alla propria area di competenza, nel rispetto delle politiche e delle procedure di qualità aziendali ed in accordo alle normative vigenti (leggi, norme GMP, FDA, etc.).

FAQs

What is the primary responsibility of the Quality on the Floor Specialist?

The primary responsibility is to conduct Batch Record Review for GMP lots while ensuring compliance with company procedures, quality standards, and applicable regulations.

What educational background is required for this position?

A degree in Chemistry, Pharmacy, Biology, or a related scientific field is required.

How many years of experience are necessary for this role?

A minimum of 2 years of experience in pharmaceutical environments in roles related to Quality Assurance or Production is required.

Is shift work required for this position?

Yes, the position requires availability to work on shifts in a continuous cycle (7x3).

Is proficiency in English necessary for this job?

Yes, a good knowledge of the English language is required.

What are the qualities required to excel in this role?

Strong teamwork capabilities and excellent relational skills are essential to succeed in this position.

Are there opportunities for continuous improvement within the role?

Yes, the Quality on the Floor Specialist participates in continuous improvement initiatives by collaborating with the Production Department and the PPI Team.

How does the Quality on the Floor Specialist promote Quality Culture?

The Specialist promotes Quality Culture by encouraging problem sharing and corrective actions through regular huddles within the Production Department.

What kind of training does this role involve?

This role involves training staff on Quality on the Floor activities and related competencies in alignment with company procedures.

Will the Quality on the Floor Specialist collaborate with other departments?

Yes, they will collaborate with Quality Operations and other Quality Specialists to ensure proper execution of investigations and identification of corrective actions.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.