QA Assistant

1 giorno fa

Borgo San Michele, Lazio, Italia Altro Tempo pieno

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 Control Job Category: Business Enablement/Support All Job Posting Locations: Latina, Italy Job Description About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for QA Assistant to be in Borgo San Michele – Latina.
Purpose For our manufacturing site in Borgo San Michele (Latina), we're looking for a permanent hire to join the Quality team. The role focuses on making sure our products fully comply with national and international pharmaceutical regulations, both in terms of quality control and documentation. You'll be part of the Quality Assurance team, helping ensure that processes and products meet GMP and internal quality standards. This includes reviewing procedures and working with quality systems and tools.
As a QA Assistant, you will: Perform all controls required by procedures for second-level approval of Batch Records.
Act as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records.
Ensure that investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented.
Investigate complex quality issues (non-conformances) and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure.
Ensure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures.
Support the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions.
Participate in cross-functional meetings to define site business priorities and organize team activities in line with defined capacity, ensuring execution of both standard and fast-track activities.
Contribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary.
Actively participate in the department's preparation for Regulatory and Customer inspections and act as Subject Matter Expert (SME) during inspection execution.
Qualifications / Requirements Master's degree or diploma in a scientific field, or an equivalent combination of education and experience in the pharmaceutical industry.
At least 2 years of experience in quality field in a pharmaceutical company, and experience as an investigator.
Excellent English language skills.
Good knowledge of Microsoft Office suite.
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 these. 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 fo