QA Manager e-Compliance (m/f)

Novartis
  • Kundl
  • Vollzeit
  • Berufserfahrung
  • 13.12.2018

Come join us and become a part of our world. Together we can discover new ways to improve and extend people's lives. As part of the global Novartis Group our sites in Kundl and Schaftenau are specialized in development and production of antibiotics and biologics.

QA Manager e-Compliance (m/f)

Kundl

Area of Responsibility

  • Ensuring computerized systems compliance in line with GxP regulations and Novartis requirements throughout the Life Cycle of the systems, e.g. local IT, laboratories and production
  • Support and implementation of global QA initiatives in computerized system validation (CSV) and Data Management
  • QA expertise / guidance during validation of computerized systems, change control, testing, deviation management and related activities to ensure compliance with regulatory and operational principles
  • Review and approval of initial validation documents of computerized systems (e.g., quality plan, validation protocol, GxP risk assessment, validation report etc.)
  • Support for internal training programs and e-compliance events, authority inspections and response to observations as well as evaluation of suppliers of computerized systems
  • Assistance and approval in periodic compliance reviews, monitoring of risk mitigation activities
  • Assistance with risk identification, assessment and plans for computerized laboratory systems
  • Monitoring of applicable regulations and optimization of established procedures
  • Ensuring CSV governance, QA and performance measurements on computerized systems
  • Liaising between IT, business functions and the QA in the validation of computerized systems
  • Conducting GMP self-inspections and GMP training
  • Escalating critical incidents according to the escalation process

Qualifications

Education: Any technical university/academy degree or adequate education with work experience
Languages: fluent in English, ideally fluent German (minimum intermediate German)
Experience: Knowledge of Computerized Systems Validation and maintenance of Process and Distributed Control Systems, laboratory systems, IT systems or software applications; knowledge in cGMP, Annex 11, 21CFR Part 11 requirements and GAMP; experience in vendor audits, project management.

Please apply online under the following link Online Application (Job ID 253435BR)
Contact: Oskar Dajerling, Recruiter

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR48,718.04 per year).

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Tel. 05338/200-0
www.novartis.at

Novartis

Pharma, Chemie, Biotech
501+ Mitarbeiter

Über uns

Als Teil der weltweiten Novartis Gruppe sind wir an vier Standorten in Österreich (Kundl, Schaftenau, Unterach/ Attersee und Wien) auf die Erforschung, Entwicklung, Produktion und den Vertrieb von Arzneimitteln spezialisiert. Seit über 70 Jahren werden Arzneimittel in Kundl biotechnologisch hergestellt.…