Quality Assurance Associate – Master Data

Biopharma Asia; Latina; Hybrid; EUR 30,000 - 49,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Recognition programs

Job summary

Johnson & Johnson is seeking a Quality Assurance Associate – Master Data in Latina, Italy. You will ensure Master Data quality, approve production documents, and support GMP-compliant processes across the site.

The role demands a Master’s degree in a relevant field, 12 months pharma experience, and strong English and Office skills. MES/PAS-X and SAP knowledge are a plus. 12-month fixed-term contract.

Qualifications

• Master's degree or equivalent in a relevant field (Chemistry, Pharmacy, Bio, Eng, CompSci).
• 12 months of experience in pharma or similar.
• Excellent English language skills.
• Good knowledge of MS Office package.
• MES systems knowledge, preferably PAS-X, and SAP is a plus.

Responsibilities

• Approve production documentation (Master Batch Records) and master data for materials, equipment and resources, ensuring on-time and quality.
• Monitor cycle time and coordinate with global group for Master Data approvals.
• Control and ensure data quality for Master Data per GMP requirements.
• Collaborate with cross-functional project teams (NPI, Tech Transfer, Technical Launch, Validation Process) to ensure product launches.
• Support quality processes including handling non-conformities, CAPAs and Change Controls.
• Resolve plant-level issues related to products, processes, equipment, facilities and utilities to ensure quality and safety.
• Act as QA representative in company projects to uphold quality aspects.
• Serve as SME for Data Integrity to ensure proper data governance and system capabilities.
• Ensure GMP document approvals for IT systems and equipment; ensure validated systems and proper documentation.
• Provide QA support to Production for 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 (QC)

Quality Management Systems (QMS)

Quality Standards

Report Writing

Education

Master's degree in Pharmaceutical Chemistry/Technologies, Pharmacy, Chemistry, Biology, Engineering, Computer Science

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 normativa 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 ai 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 assicurare 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 daappropriata 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.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s what you can expect

Application review: We’ll carefully review your CV to see how your skills and experience align with the role.

Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through this.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey, your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process!

Preferred 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.