Qa - Production Quality Specialist

GiGroup H-7241; Frosinone; Sur place; EUR 35 000 - 52 000; Plein temps

Résumé du poste

Grafton LifeScience cerca un/una Production Quality Specialist per garantire la conformità nel Dipartimento di Produzione, gestendo documentazione, CAPA, deviazioni e audit in un ambiente regolamentato e dinamico.

Il ruolo prevede contratto a tempo determinato, posizione presso Ferentino (FR) e orario lavorativo da lunedì a venerdì, flessibile 8:30-9:30. Titolo di studio richiesto: laurea triennale in discipline scientifiche.

Qualifications

• Esperienza in reparti sterile manufacturing/produzione
• Conoscenza delle normative GMP
• Inglese scritto e parlato livello B2

Responsabilités

• Fornire supporto documentale al reparto di produzione.
• Gestire CAPAs utilizzando TrackWise.
• Coordinare l’apertura e la gestione dei Change Control Forms (CCF).
• Collaborare con il Quality System per rivedere e aggiornare le SOP.
• Condurre e gestire attività formative di reparto.
• Preparare e presentare documenti e procedure di conformità.
• Identificare e risolvere issue di qualità con i team interessati.
• Gestire audit interni, dei clienti e normativi.

Connaissances

GMP knowledge

English (B2)

Formation

Laurea triennale in disciplina scientifica

Description du poste

Luogo di lavoro: Frosinone

Grafton LifeScience* is a dedicated team focused on enhancing the experiences, skills, and potential of candidates in Sales & Marketing, Clinical Research, Regulatory, and Operations within the Pharmaceutical and Medical sectors. We also specialize in roles related to customer support in the health-impacting distribution field (Pharmacies and Parapharmacies).

In partnership with an integrated CDMO with around 60 locations worldwide, specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, we offer an opportunity for

Production Quality Specialist

Summary

The main function of a Quality Specialist is to ensure compliance within the Manufacturing Department by managing documentation, CAPAs, deviations, and audits. This role supports continuous improvement initiatives and collaborates across departments to uphold quality standards in a fast-paced, regulated environment.

Job Responsibilities

• Provide documentary support to the production department.
• Manage CAPAs using the TrackWise system.
• Coordinate the opening and management of Change Control Forms (CCFs).
• Collaborate with the Quality System Department to review and update SOPs.
• Conduct and manage departmental training activities.
• Prepare and present compliance documents and procedures.
• Identify and resolve quality issues in collaboration with relevant teams.
• Manage internal, customer, and regulatory audits.

Do you have these skills and requirements?

Requirements: 1-2 years

• Previous work experience (not necessarily in the same role) in sterile manufacturing/production departments
• Knowledge of GMP regulations
• English (written and spoken) B2

Preferred skills:

• Participation in regulatory audits
• Participation in internal and external audits
• Quality Assurance in a manufacturing/production environment

Qualifications:

• Bachelor's degree (3-year) in a scientific discipline

Contract Offer: Fixed-term agency contract 05/10/2026- 05/04/2026. CCNL Chimico-Farmaceutico, livello D1.

Working time weekly: Monday to Friday daily / flex 8.30-9.30

Place of work: Ferentino (FR)

Grafton LifeScience is a specialization of Gi Group Spa authorized to operate by the Ministry of Labor and Social Policies (Authorization No. 26/11/2004 PROT. 1101 - SG).

The offer is intended for candidates in compliance with Legislative Decree No. 198/2006 and subsequent amendments, as well as Legislative Decrees No. 215 and No. 216 of 2003 on equal treatment.

Candidates are invited to read the privacy notice pursuant to Articles 13 and 14 of EU Regulation 679/2016 at the following address: www.Gigroup.It/privacy-candidati