Pds Quality Operations Analyst

GiGroup H-7241; Monza; Presencial; EUR 42 000 - 52 000; Tempo integral

Resumo da oferta

Grafton LifeScience cerca un QC PDS Quality Operations Analyst per unirsi al team PDS, lavorando in un ambiente GMP/GLP e contribuendo allo sviluppo e alla fornitura di prodotti e tecnologie avanzate per sanità e protezione ambientale.

Il ruolo prevede verifica di attività analitiche, gestione della documentazione e supporto operativo in laboratorio, con contratto a tempo determinato di 12 mesi e sede a Monza.

Qualificações

• Esperienza in laboratorio GMP QC.
• Familiarità con HPLC, UV-Vis, FT-IR e test compendiali (pH, osmolarità, contenuto del contenitore, aspetto).
• Capacità di rispettare scadenze critiche.
• Buone capacità comunicative e attenzione ai dettagli.
• Buone capacità di documentazione e revisione analitica.

Responsabilidades

• Verificare attività analitiche e documentazione generate dal laboratorio QC PDS, garantendo accuratezza, integrità dei dati e conformità GMP/GLP.
• Revisione delle analisi e della documentazione relativa a rilascio prodotto, studi di stabilità, convalida e trasferimento metodi, APIs.
• Ricevere formazione di laboratorio per operare come QC PDS Laboratory Analyst.
• Fornire supporto pratico alle attività di laboratorio quando necessario.

Conhecimentos

GMP QC lab

HPLC

UV-Vis

FT-IR

Plausible documentation

Analytical review

Formação académica

Biotecnologia o Chimica Farmaceutica (CTF) o campo affine

Ferramentas

HPLC

UV-Vis

FT-IR

pH

osmolarità

Descrição da oferta de emprego

Luogo di lavoro: Monza

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.

We offer an environment that values performance, quality, and innovation, providing the resources and opportunities to develop your expertise and grow your career while contributing to our mission of enabling our customers to make the world healthier, cleaner and safer.

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"