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Specialist

Specialist

Novo Nordisk

10 - 15 years

5 - 9 Lacs

Bengaluru

Posted:7 hours ago| Platform:

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Skills Required

manufacturing processes sme aseptic assurance manufacturing injectables capa autoclave usfda data validation production ipqa business services documentation microbiology gmp cip parenteral change control quality assurance qms sterile

Work Mode

Work from Office

Job Type

Full Time

Job Description

Novo Nordisk Global Business Services (GBS) India
Department GCM DP RoW
Job Location Hyderabad
Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). !
The Position
As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners.Your key responsibilities will include:

Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit.

Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards.

Provide training, share best practices, and review and approve validation documents to safeguard compliance.

Offer oversight and support during the planning and execution of validation and qualification activities.

Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers.

Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines.

Qualifications

Bachelor’s /Master’s degree in engineering.

Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment.

Expertise in aseptic manufacturing processes is non-negotiable.

Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals.

Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail.

Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment.

About the Department
GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity.With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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