Change Control Coordinator

REQ-10009889
6月 03, 2024
India

摘要

Handling of technical change control as well as responsibility for the documentation and coordination of the necessary activities during plant changes in Agile

About the Role

Change Control Coordinator

About the Role:

Handling of technical change control as well as responsibility for the documentation and coordination of the necessary activities during plant changes in Agile

Key Responsibilities: 

  • Should have good engineering knowledge in the Bio-Pharmaceutical Plant in the areas of
    • Facilities that are involved as infrastructure or in the manufacturing process, e.g. Ultrapure water systems, building services, manufacturing, packaging equipment (direct and indirect impact systems)
    • the qualified status of a room or its classification (cleanroom zone E, D, C, B, A).
    • the software and computer systems managed by Engineering.
    • for new acquisitions of plants and systems/Equipment’s
    • on measuring equipment
    • SAP/Quality Management system software skills
    • Project planning Skills
    • Asset life cycle management skills eg maintenance documents  and its metrics review
  • Should have sound knowledge about the Nomination of all participants in the QMS change phase from reviewer – approver.
  • Should be good in all Engineering related changes which requires an evaluation & followed by a Registration Representative
  • Changes to ER/ES relevant systems, must be evaluated by eCompliance
  • In the case of devices, a DHF (Device Documentation File) evaluation may also be required. In the case of combination products, assembled and/or packaged, the MS&T "device expert" must check for adjustments with regard to device documentation (DHF file).
  • Implementation of the change and processing (or delegation) of the tasks defined in the implementation plan
  • Coordination of the change until completion

Essential Requirements:

  • 5+ years of experience in handling change controls within pharmaceutical sector
  • Very good knowledge of German and good knowledge of English (spoken and in writing)
  • Experience in the GMP or pharmaceutical sector.
  • Technical education, high level of personal responsibility, good communication skills

Desirable Requirements:

  • Degree or equivalent experience in Engineering with experience in Pharmaceutical Industry/ specifically GMP background

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

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
India
Hyderabad (Office)
Technical Operations
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.

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REQ-10009889

Change Control Coordinator

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Source URL: https://www.novartis.com.cn/careers/career-search/job/details/req-10009889-change-control-coordinator

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  2. https://talentnetwork.novartis.com/network
  3. https://www.novartis.com/careers/benefits-rewards
  4. https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Change-Control-Coordinator_REQ-10009889
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