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Novartis India

Specialist Quality Operations

Early Applicant
  • a month ago
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Job Description

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 well help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

More Info

Industry:Other

Job Type:Permanent Job

Date Posted: 09/10/2024

Job ID: 95653037

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Last Updated: 20-11-2024 08:20:39 PM