Quality Assurance Associate – Master Data

7175-Janssen Cilag S.p.A. Legal Entity; Borgo San Michele; On-site; EUR 30,000 - 49,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (12 weeks minimum)

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Quality Assurance Associate – Master Data based in Latina, Italy, on a 12-month fixed-term contract, to join the Quality Assurance area responsible for Master Data and GMP compliance. The role involves approving master data, collaborating with cross-functional teams, supporting QA processes, and acting as SME for Data Integrity.

Candidates should have a Master’s degree in relevant fields, 12 months pharma experience, strong English, and knowledge of MES/PAS-X and

Qualifications

• 12 months of pharma industry experience.
• Excellent English language skills.
• Good knowledge of Office Suite.

Responsibilities

• Approve production documentation (Master Batch Records and recipes) and master data for materials, equipment and resources, ensuring timely delivery and data quality.
• Control and guarantee management of critical Master Data data per GMP and quality/compliance procedures.
• Collaborate with cross-functional project teams to ensure product launch dates.
• Support quality processes, including deviations handling and CAPA requests.
• Manage site-wide issues affecting products, processes, equipment/tools to ensure quality, safety and efficacy.
• Act as QA representative in company projects to ensure quality aspects.
• Serve as SME for Data Integrity, ensuring governance and system capabilities.
• Approve GMP documents related to IT systems and equipment.
• Ensure use of qualified/validated systems with proper documentation and deviation handling.
• Provide effective QA support to Production to overcome critical situations.

Skills

Accountability

Administrative Support

Compliance Management

Detail-Oriented

Document Management

Execution Focus

Goal Attainment

Human-Centered Design

Internal Controls

Process Oriented

Quality Control

Quality Management Systems

Quality Standards

Report Writing

Education

MSc in Pharmaceutical Chemistry and Technologies / Pharmacy / Chemistry or Biology / Engineering / Computer Science

Tools

PAS-X

SAP

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Assurance Job Category: Business Enablement/Support All Job Posting Locations: Latina, Italy

Job Description

A proposito di Innovative Medicine La nostra esperienza in Innovative Medicine è ispirata dai pazienti, la cui conoscenza alimenta i nostri progressi scientifici. I visionari come te lavorano in team che salvano vite sviluppando le cure del domani. Unisciti a noi nello sviluppo di trattamenti, nella ricerca di cure e nel pionieristico percorso dal laboratorio alla vita, sostenendo i pazienti in ogni fase del percorso. Per ulteriori informazioni, visitare il sito Web https://www.jnj.com/innovative-medicine Stiamo cercando il miglior talento nel ruolo di Quality Assurance Associate – Master Data basato a Latina. La posizione prevede un contratto a tempo determinato di 12 mesi. Scopo: La risorsa scelta sarà inserita nell'area Quality Assurance, che ha la responsabilità di assicurare, attraverso la verifica del rispetto di procedure operative standard e mediante opportuni strumenti, che la qualità del prodotto sia conforme alle specifiche e normative vigenti (GMP). In particolare la risorsa si occuperà di:

• Approvare la documentazione di produzione (Master Batch Record e ricette) e dell’anagrafica dei materiali, degli equipment e delle risorse (Master Data), assicurando il rispetto dei tempi e la qualità dell’intero processo, monitorandone il cycle time e coordinandosi con il gruppo globale per l’approvazione dei Master Data.
• Controllare e garantire la gestione dei dati critici relativi al Master Data, in accordo alle GMP ed ai requisiti di qualità e compliance definiti dalle procedure aziendali assicurandone la relativa approvazione.
• Collaborare e partecipare come riferimento Quality per il sito ai team crossfunzionali di progetto (New Product Introduction, Technology Transfer, Technical Launch, Validation Process) al fine di assicurare le date di lancio dei prodotti sul mercato.
• Svolgere attività di supporto nei processi di qualità, inclusa la gestione delle non conformtà, il monitoraggio dell’implementazione di azioni correttive/preventive e richieste di cambiamento (Change Control) legate ai progetti assegnati.
• Gestire la risoluzione delle problematiche dei diversi reparti dello stabilimento in relazione alla gestione dei prodotti, dei processi, di equipment/facilities/utilities al fine di garantire la qualità, sicurezza ed efficacia dei prodotti.
• Agire come rappresentante QA in progetti aziendali al fine di curarne gli aspetti di qualità.
• Agire da Subject Matter Expert (SME) di Data Integrity, al fine di garantire l’implementazione dei processi che assicurino una corretta e appropriata gestione dei dati sia in termini di definizione e gestione delle system capabilities che del loro processo di revisione e approvazione.
• Assicurare l’approvazione dei documenti GMP relativi ai sistemi informatici e agli equipment.
• Garantire l’utilizzo esclusivo di sistemi qualificati/validati, corredati da appropriata documentazione e assicurare la corretta gestione di eventuali deviazioni.
• Garantire un’efficace assistenza al Servizio di Produzione, fornendo le soluzioni necessarie al superamento di situazioni critiche.

Qualifiche / Requisiti

• Laurea magistrale in Chimica e Tecnologie Farmaceutiche, Farmacia, Chimica o Biologia, Ingegneria, Informatica, titoli equivalenti
• Esperienza di 12 mesi in settore farmaceutico o simile;
• Ottima conoscenza della lingua inglese;
• Buona conoscenza del pacchetto office.
• La conoscenza di sistemi MES, preferibilmente PAS-X, e di SAP costituisce titolo preferenziale.

Required Skills:

• Accountability
• Administrative Support
• Compliance Management
• Detail-Oriented
• Document Management
• Execution Focus
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Report Writing

The anticipated base pay range for this position is: €30,400.00 - €49,450.00

Benefits: In addition to base pay, we offer the following benefits* an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information: At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.