Ensure analytical Life Cycle Management for commercial/existing products and ensure timely analytical implementation for new projects with focus on raw materials.
Responsible for managing all analytical aspects with focus on raw material within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
About the Role
Your responsibilities include, but are not limited to:
1. Management and oversight of all analytical activities related within responsible projects with focus on raw material analytics
2. Ensure timely analytical implementation (Method Transfer and Method Validation) for raw material testing for new projects in the course of product transfers
3. Single point of contact for internal and external clients and contract laboratories with focus on raw material analytics
4. Scientific analytical support for quality control, production, registration and marketing
5. Life-cycle management of analytical methods with focus on raw materials, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance
6. Subject matter expert in health authority inspections and Customer Inspections
7. Budget planning and budget tracking; support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T
8. Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents)
Qualifications
1. Ph.D. in chemistry of biochemistry or at least 5 years of experience within pharmacy in project management of operational manager
2. Analytical Expertise, preferably for raw materials
3. Knowledge of GMP
4. Raw Material Testing according to Ph.Eu. and USP
5. Quality Focus, Project Focus, Accountability and Result Driven
6. Team Player able to make decisions, strong in Digital & Technical
7. Fluent English or German language
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area: Quality
Job Type: Full time
Employment Type: Befristet (Befristet)
Shift Work: No
#J-18808-Ljbffr