Job Description Summary
Location: Ivrea, Italy #onsiteRole Purpose:
Support the pilot plant ramp up and operationalization process through the creation compliant manufacturing and QC-related quality system which comprises master batch records, logbooks, forms, procedures. Support qualification and validation activities managing and reviewing the related documentation.
Ensure the compliance of all the business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, in preparation of external and corporate audits and Health Authority inspections.
Maintain the site compliance through 3rd party management, trainings, change controls, self-inspections, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) monitoring.
Job Description
Major Accountabilities:
Support site qualification and validation activities (advising, review, approval).
Implementation of Quality Systems (incl. documentation management)
Supplier management activities (agreements, oversight, audit).
Preparation/support and coordination of CAPA/follow -up
Audit and inspection preparation and support, ensure applications, certificate maintenance etc. to local HA
Change control review/approval
Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
KPI/KQI trending
Handling of technical complaints, deviations, quality events related to Novartis products, systems or processes.
Key Performance Indicators:
Successful support of projects with agreed quality and delivery dates, passing of internal & external inspections.
Meet quality & timelines for all projects
Act in accordance with Novartis standards.
The number and severity of cGMP issues identified during internal and external audits
Year-end figures within budget; Successful coordination of departmental operational activities
Work Experience:
Change Control Management
Audit & Inspection Management
Compliance Risk Management
Good Manufacturing Practices (cGMP)
GxP Experience
KPI Reporting
Quality Management System
Prerequisites:
Minimum of 5 years in pharmaceutical industry (sterile preferred)
Previous experience in HAs inspection support (backroom / SME)
Experienced in QMS document management
Fluency in English
Experience working with electronic quality systems (e.g. change controls, deviations, OOX, complaints, etc.)
Strong quality mindset, documentation, communication, and cross‑functional collaboration skills.
Languages:
Italian
English
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
Top Skills
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
