Job ID: REQ-10014057Date: Aug 06, 2024Location: ItalySummaryThe Quality Assurance Specialist is responsible for supporting the maintenance at the local level of the quality management system as per GMP regulation and corporate guidelines, ensuring that all relevant external and internal requirements are implemented, monitored for performance, and adhered to.About the RoleMajor accountabilities:Assure the respect of the GMPs and Health Authorities requirements at local level.Contribute to maintain the local quality system as per GMPs and corporate guidelines.Redaction and review of SOPs, records, protocols, and reports according to GMPs, National/ Corporate Guidelines, and health authorities' requirements.Registration and archiving of documentation at local level.Manage the GMP logbooks (distribution, archiving, and revision).Collaborate in the management of Annual Product Reviews (redaction and review).Manage training records, execution at local level of staff GMP training, and redaction of the Training Annual Plan.Support the Quality Site Head during escalation cases in case of critical issues.Participate in self-inspections as per approved annual plan and in external audits (Health Authorities, Certified Bodies, Supplier).Support in management and redaction of Out of Specifications, System Suitability Test failure, Out of Trend, Deviations, CAPA, Change Controls, Complaints according to cGMP and reference SOPs.Collaborate in the annual suppliers' qualification in accordance with related SOPs.Fill in the KQIs files.Prepare and print the batch documentation.Support the QPs in the batch record review.Support at local level the QA Department in assuring the execution of qualification, maintenance, calibration, and revalidation programs; and in managing the external inspections follow-up.Key performance indicators:Inspection management (no critical observations during Health Authorities inspections).Completion of all relevant quality records within applicable time frame, with measured overdues.Functional Breadth.QC/QA in pharmaceutical industry/biotech with environmental monitoring.Skills:Dealing With Ambiguity.GMP Procedures.QA (Quality Assurance).Quality Control (QC) Testing.Quality Standards.Technological Expertise.Languages:Education: Pharmaceuticals, Chemical or Biological degreeLanguages: Fluent in English verbally and in writingExperiences:1+ years of experience in a Quality department.Strong affinity with and awareness of quality issues.Good organizational skills including attention to details.Knowledge of quality system (GMP).Basic knowledge of regulatory requirements.Shows the appropriate sense of urgency around given tasks.Ability to work in a team.Why Novartis:Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting, and inspiring each other.
Combining to achieve breakthroughs that change patients' lives.
Ready to create a brighter future together?
Learn more.Join our Novartis Network:Not the right Novartis role for you?
Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Join here.Division: OperationsBusiness Unit: Innovative MedicinesLocation: ItalySite: ForliCompany / Legal Entity: IT63 (FCRS = IT063) AAA Mol.
Ima.
Italy s.r.lNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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