Specialist Quality Operations

Summary

Provide quality support in compliance with cGMP requirements and Novartis Quality Management System. Manage Quality aspects & projects within area of responsibility.

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