Summary
- Ensure compliance and further development, support, maintenance and constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPIs) & quality indicators (KQIs). Support implementation of effective & efficient processes that fulfill regulatory requirements & expectations in a sustainable way for the global Novartis portfolio of products.
About The Role
Major accountabilities:
- Ensure that the Quality System is compliant with the global guidelines and that all relevant regulations and legal requirements are adhered to set up a quality system with GxP and monitor the periodic inspection and updating quality-relevant processes -Continually improve and harmonize the quality-relevant processes, strengthen the awareness of quality, technical service, quality-relevant product tests, eliminate barriers relevant to the process and anticipate quality problems.
- Support the departments in case of Quality assurance questions -Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatorycompliance risks -Performs self-assessments -Support a compliance and quality culture -Provides expert advice and input and harmonize and continuous optimize processes within QA area -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Achieve agreed targets in terms of quality, time & cost throughsuccessful project teamwork resulting in greater customer satisfaction -Exemplify Novartis Values & Behaviors and other professionalcompetencies in support of the assigned unit and the provision ofappropriate services.
Minimum Requirements:
Work Experience
- Functional Breadth.
- Fix-its/Turnarounds.
- Project Management.
Skills:
- Compliance Requirements.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gxp.
- Industry Standards.
- Project Management.
- Quality Management Systems (Qms).
- Quality Standards.
- Risk Management.
- Self Awareness.
- Technological Expertise.
Languages :
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