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Advanced Quality Professional - Change Request and Deviation

Category:  Quality
Location: 

Bangalore, Karnataka, IN

   

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you.

 

About the department

Novo Nordisk (NN) Quality India department was established in May 2015, with a purpose of delivering services related to quality processes such training coordination and document control, NovoGloW (Quality & Compliance Management platform), Records Management to various internal clients within Novo Nordisk. The main purpose of our existence is to provide superior service to our stakeholders consistently and add value to the processes in terms of standardisation and efficiency.

 

The position

This position holder will provide compliance support to International Operations (IO) and North America Operations (NAO) in Deviations, Validations and Change Request (CR) processes. Compliance support will have focus on, but not limited to, Deviations, cold chain validation and CR handling. Also, you will collaborate and coordinate with OQCP/headquarter (HQ) specialists to provide timely compliance support and follow-up on defined goals and tasks.


In collaboration with OQCP specialist(s), you will be supporting the implementation, maintenance and continuous improvement of the Deviations, cold chain validation setup and CR handling in IO and NAO. You will ensure that timely and high Quality support is provided to the line of business. The support would entail the following, but not limited to, end to end (initiation to closure) handling of Deviation and Change requests in collaboration with colleagues within OQCP and Quality Responsible Persons (QRPs) across operations, supporting cold chain equipment (cold rooms, refrigerators, cold boxes etc) qualification activities remotely i.e. preparation of qualification documents, review of qualification documents from vendors, preparation of qualification reports etc. 


Apart from this, You will be helping the team in improvement projects within Deviations, cold chain validation, CR handling, and other relevant processes such as Distribution, Annual Product Review etc. You will be expected to report to Management in OQCP/Operations & Staffs Quality (OSQ) as requested. Your colleagues in OQCP, Quality Responsible Persons (QRPs) at all levels globally and deviation, validation and CR Subject Matter Experts in HQ will be your stakeholders for this role.

 

Qualifications

We expect you to hold the below skills and knowledge:

 

  • Bachelor’s degree or equivalent
  • Overall, 4-6 years of experience working in a global corporate company
  • Minimum 4+yrs of relevant experience with Bachelors OR 2+yrs with Masters
  • Work experience from pharmaceutical industry
  • Strong in handling Deviations
  • Good understanding of external quality/regulatory requirements and trends within Deviation, cold chain validation, and CR handling.
  • Able to adapt to new set-ups/concepts within the Deviation, cold chain validation and CR handling and other quality processes.
  • Trained and worked according to international validation principles
  • Experience with Change Request handling
  • Experience with GMP/GDP on operational level
  • Intercultural experience
  • Being committed, open and honest
  • Able to deliver under pressure and handle stressful situations
  • Work structured, solution oriented and should have a eye for details
  • Being responsible, detail oriented, service-minded and reliable in relation to colleagues and stakeholders
  • Very good communication skills

 

Working at Novo Nordisk

In Novo Nordisk, you will be met with trust, interesting challenges and rich opportunity for personal and professional growth. You will be investing your unique skills in an environment focused around a competent sharing of knowledge, and where your talent and experience is valued. We are proud to use our dedication and our capabilities to make a difference for millions of people around the world.

 

Contact

For further information, please contact Ekta Singh at eksn@novonordisk.com.

 

Deadline

25 April 2021.

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.