Summary
About the Role
Major accountabilities:
Have expertise in Supplier Quality management and QMS activities. Drafting of QRA, QAA and AMR documents. Handling Supplier Qualifications and change notification.
Interpret and compile APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
Create and review GxP documents including SOPs, working procedures, trend reports, qualification
reports and technical investigations, as and when needed.
· Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports
· Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality
Operations services in support of product quality compliance and regulatory workflows
· Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure
appropriate execution of service deliverables
· Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required
· Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed
product quality standards and service level agreements
· Support implementing service quality and process improvement projects, CAPA management within
Quality Service Centers
· Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket
management tools and other internal systems and processes
Requirements for the role
Minimum 6 years of experience in Quality assurance activities in pharmaceutical company.
GxP knowledge, Basic IT knowledge
Good communication, presentation and interpersonal skills
Experience of working closely with the global stakeholders
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
TEst Hello
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.