QA Compliance Expert
Überblick
KI-Zusammenfassung
Ensure compliance and development of quality systems, supporting projects and reporting KPIs/KQIs. You will coordinate inspections and maintain oversight on CAPAs.
Erforderliche Skills
Ausbildung
Sprachen
Deine Aufgaben
- Coordinate and prepare Health authority inspections, internal inspections, and self-inspections
- Support inspection execution as Back Office Lead
- Maintain oversight on CAPAs from audit and inspections
- Support reporting on CAPAs
Benefits
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Unternehmen
Novartis
Novartis reimagines medicine to improve and extend people’s lives, aiming to become the most valued and trusted medicines company in the world.
Unternehmenskultur
Novartis values its associates, driving daily ambitions and supporting a diverse and inclusive working environment.
Diversity & Inclusion
Novartis is committed to building an inclusive working environment and diverse teams, representative of the patients and communities we serve.
Originale Stellenbeschreibung
QA Compliance Expert
Schaftenau | Part time
Band
Level 4
Job Description Summary
This is a part time job: 70% employment
Ensure compliance and further development, support, maintenance and continuous review of quality systems and support projects as well as reporting of the necessary key performance indicators (KPIs) & quality indicators (KQIs). Support in the implementation of effective and efficient processes that meet regulatory requirements and expectations in a sustainable manner for the global Novartis product portfolio.
Job Description
Key Responsibilities:
Your responsibilities include, but are not limited to:
• Coordination and preparation of Health authority inspections, internal inspections (global compliance and auditing) and self-inspections. Support inspection execution as Back Office Lead and inspection follow up. Maintain oversight on CAPAs from audit and inspections and support reporting thereon.
Essential Requirements:
• Work experience in a GMP regulated environment in the pharmaceutical industry
• Accountability and good communication skills
• Continued learning (dynamic knowledge development)
• Takes over responsibility and delivers reliably
• Teamwork: Good Cooperation with different Departments and Functions
• Experienced problem solving
• English fluent, German basic
Skills Desired
Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Model