Job Description

About the role

Position Purpose:
-Manages Quality aspects & projects within area of responsibility. -Ensures and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems.

Major Accountabilities:
-Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance -Support exception investigations -Review & approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person - Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Responsible for the evaluation of chemical synthesis routes to identify, categorize and control possible mutagenic impurities in active pharmaceutical ingredients (API) and drug products. Assessment of potential degradation pathways of APIs in final drug products with the purpose to identify and assess possibility for the formation of potentially mutagenic impurities and ways to prevent this. Participate in cross- functional technical teams as required to deliver on projects. Involved in paper- based assessment of toxicological data for mutagenic, genotoxic and nitrosamines Conduct of feasibility studies for generic API synthesis and synthesis of by-products, degradation products and related substances. Protection of intellectual property in the field of organic synthesis. Utilize scientific expertise and chemical database to generate solutions to problems. Maintaining laboratory logbooks and other project documents in accordance with good documentation practice (data integrity) and HSE requirements. Co-ordination of laboratory work performed by technicians. Creation of relevant instructions, protocols and reports in accordance with scientific and regulatory standards. Other tasks as assigned by the supervisor and tasks based on a specific appointment. Implementation of and adherence to all the instructions and requirements for safe work, environment protection and property protection. Responsibility for personal and professional development, willingness

Role Requirements

Collaborating across boundaries Functional Breadth QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones English Quality Control (QC) Testing Knowledge of GMP Knowledge of IT Applications & tools Quality Standards Quality Assurance

Functional Area

Quality

Division

SANDOZ

Business Unit

Quality STO

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis