QA Compliance Team Leader
QA Compliance Team Leader
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description Summary
The QA Compliance Team Leader supports effective GxP Compliance and/or Audit activities operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP legal and regulatory requirements and through internal audits KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).Supports the preparation and management of external and corporate audits and Health Authority inspections.
Job Description
Major accountabilities:
Planning and supporting PQR/APQR activities.
Support site qualification and validation activities (planning advising review).
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.
Change control review/approval.
Ensure local DI and eCompliance oversight (training inspections plan risk ID etc.).
Ensure process quality assurance according to regulations.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Minimum Requirements:
Scientific degree.
Previous experience in a Quality Assurance department within a pharma manufacturing environment.
People management skills.
Fluent in Italian and English.
Skills Desired
Action-Oriented Compliance Requirements Continued Learning Dealing With Ambiguity Functional Skills Gmp Procedures Gxp Industry Standards Process Optimization Qa (Quality Assurance) Quality Standards Self-Awareness Technological Expertise Technological IntelligenceEmployment Type
Full-Time
