Specialist Quality Operations

☞ Novartis

見る: 101

更新日: 06-05-2024

場所: Hyderabad / Secunderabad Telangana

カテゴリー: 経営管理 生産/操作 薬剤師/薬剤師

業界: Healthcare

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仕事内容

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Job Purpose:
Provide Quality Service in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.

Your responsibilities include, but not limited to

  • Prepare Regulatory Statements/declarations, Quality Assurance Agreement, Quality Risk Assessment for excipients, Regular Material-/Supplier-Monitoring and packaging material as per agreed tasks with the customers.
  • Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
  • Hold accounts in workflow applications (like SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables
  • Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
  • 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.
  • Assist the department on any other ad hoc administrative activities as per business requirements. Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable

Minimum requirements

  • M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
  • Min 3yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.
  • GxP-knowledge, Broad IT-knowledge
  • Fluent in English (written and spoken)
  • Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis! Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Division

Novartis Technical Operations

Business Unit

NTO QUALITY

Country

India

Work Location

Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No
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締切: 20-06-2024

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