Engineering Standard Manager

REQ-10041025
fév 21, 2025
Inde

Résumé

Drive the development, implementation and continuous improvement of Engineering global business processes and systems to ensure adherence to internal Novartis requirements, standards and external regulations improving efficiency and compliance.

About the Role

Key Responsibilities:

  • Develop and maintaining simplified decision-making Global Engineering Standards for key Business Processes/Quality Systems ensuring alignment with Health Authority regulations and business requirements. Provide guidance and oversight to manufacturing sites ensuring communicating and implementation tracking.

  • Proactively reviews the Quality Systems to identify Engineering trends across the organization and in alignment with industry expectations. Ensures alignment with Novartis Quality System (QMs/QDs/ SOPs). Reviews, and provides feedback of all relevant Quality Modules and Directives. Provides input into the alignment and update of global standards.

  • Define and maintain Engineering Systems (e.g., Kneat, Agile ACC, COMOS) (including implementation of new functionalities) by executing defined roadmap in collaboration with IT. Drive its continuous improvement in compliance with Global Engineering Standards processes and benchmarking against internal Novartis and external industry standards.

  • Ensure training content is properly updated for Global Engineering Standards and Systems functionalities into applicable Management System (e.g., U4G). Active partnership with sites to ensure proper knowledge and learning capabilities.

  • Ensure Engineering Training program (matrix) is in alignment with existing effective and applicable Standards. Define minimum training requests for specific job role to facilitate onboarding process.

  • Support sites in preparation, review, and approval of responses to internal and external audits to global and local Engineering organizations. Ensure KQI are under control at global and local organization through monthly reporting.

  • Direct Interface with Quality Function to ensure alignment of Global Engineering Standards and Systems with the aim of achieving world class standards and practices, with best practice sharing across the platform sites.

  • Support as a Global Process owner for the C&Q & support for implementing the tools as part of engineering process digitalization.

Essential Requirement:

  • Degree in Mechanical/Chemical Engineering/M. Pharma with 10 - 12 years of experience in Pharmaceutical/ Chemical/ FMCG Industry.
  • Deep understanding of Project Commissioning & Qualification activities, and qualification documentation creation within pharmaceutical OSD / Injectable / API / Oncology / Biotechnology.
  • In-depth knowledge of engineering standards: Understanding industry-specific regulations, codes, and guidelines is crucial for ensuring compliance and quality in engineering process & activities.
  • Expertise in developing Engineering Standards, Standard Operating Procedures (SOPs), Templates, Work Instructions (WIs), and other technical documentation.
  • Technical Skills: Kneat, excel, power point, word
  • Proficient in project management, including planning, organizing, and coordinating with global stakeholders to successfully implement engineering programs, initiatives, and projects

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

Operations
Innovative Medicines
Inde
Hyderabad (Office)
Opérations techniques
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10041025

Engineering Standard Manager

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