TRD Sr. QA Specialist

Ivrea - Italy

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Location: Ivrea Italy #onsite

Role 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 crossfunctional 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

Required Experience:

Senior IC

Job Description SummaryLocation: Ivrea Italy #onsite Role 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 valida...