PDS Quality Operations Analyst

Gi Group SpA Filiale di Monza; Lombardia; On-site; EUR 32,000 - 42,000; Full time

Job summary

Grafton LifeScience cerca un QC PDS Quality Operations Analyst da inserire nel team, in Monza, con formazione in Biotecnologia o Chimica Farmaceutica. Il ruolo prevede revisione di dati analitici in ambiente GMP/GLP e supporto alle attività di laboratorio per procedure di rilascio e stabilità.

Il contratto offerto è a tempo determinato di 12 mesi. Orario settimanale dal lunedì al venerdì sul posto di lavoro di Monza, con formazione prevista e sviluppo di competenze analitiche avanzate nel

Qualifications

• Esperienza in un laboratorio di Controllo Qualità GMP.
• Familiarità con tecniche come HPLC, UV-Vis, FT-IR e test consolidati (pH, osmolalità, contenuto del contenitore, aspetto).
• Capacità di rispettare scadenze critiche.
• Buone capacità comunicative e attenzione al dettaglio.
• Ottima documentazione e revisione analitica.

Responsibilities

• Verifica delle attività analitiche e della documentazione generate dal laboratorio QC PDS, assicurando accuratezza, completezza, integrità dei dati e conformità alle procedure GMP/GLP.
• Revisione di test analitici e documentazione relativi a rilascio prodotto, studi di stabilità, validazione/metodi di trasferimento e APIs, utilizzando tecniche standard come HPLC, UV-Vis, FT-IR e metodi farmacopoeici.
• Ricezione di formazione laboratoristica per operare come QC PDS Laboratory Analyst.
• Supporto operativo alle attività di laboratorio e ai test analitici quando necessario.

Skills

GMP QC experience

Analytical data review

Documentation discipline

Education

Biotechnology o Pharmaceutical Chemistry

Tools

HPLC

UV-Vis

FT-IR

Job description

FILIALE: MONZASPECIALIZZAZIONE: CORE SKILL - Life Science

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).We are a team of passionate professionals working to guide our candidates towards roles and corporate environments that best match their skills and expectations.

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

QC PDS Quality Operations Analyst

Summary:

As a QC PDS Quality Operations Analyst, you will join our collaborative PDS team, working cross-functionally in a GMP/GLP-regulated environment and contributing to the development and delivery of advanced products and technologies that help address global challenges in healthcare and environmental protection.

Job Responsibilities:

• -The primary focus of this role will be the review and verification of analytical activities and documentation generated by the QC PDS laboratory, ensuring accuracy, completeness, data integrity, and compliance with applicable procedures and GMP/GLP requirements.
• -Review of analytical testing and documentation related to product release, stability studies, analytical method validation and transfer activities, and Active Pharmaceutical Ingredients (APIs), using standard analytical techniques and instrumentation such as HPLC, UV-Vis, FT-IR, and Pharmacopoeial methods.
• -You will also receive appropriate laboratory training to maintain the capability to operate as a QC PDS Laboratory Analyst.
• -When required, you may provide hands‑on support to routine laboratory activities and analytical testing.

Skills:

• Experience in a GMP Quality Control lab.
• Familiarity with techniques including HPLC, UV-Vis, FT-IR, and compendial tests (pH, osmolality, container content, appearance).
• Ability to work to critical timelines.
• Effective interpersonal skills and attention to detail.
• Strong documentation and analytical review capabilities.

Education/Experience:

• Degree in Biotechnology, Pharmaceutical Chemistry (CTF) or a related scientific field preferred.
• Experience in reviewing QC data and documentation in a GMP-regulated environment.

Contract Offer: 12 months Fixed-term agency contract. CCNL Chimico-Farmaceutico, livello D1.

Working time weekly: Monday to Friday

Place of work: Monza

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"