Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Senior Quality Professional I
• 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.
• This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills. Requires you to take independent decisions while handling the relevant tasks.
Candidate Profile :
• Bachelor’s or Master’s in Engineering/Pharmacy/Biology/Chemistry or similar
• Relevant work experience of 6-8 years in Deviation, Change Request and Validation
• Related work experience in the pharmaceutical industry is a must
• Adept in handling Deviations, trained & worked according to international validation principles and experience with Change Request handling
• Experience with GMP/GDP on operational level
• Good communication skills in talking to people at all levels of the organization as well as for presenting in large forum
• Being committed, open and honest
• Able to deliver under pressure and handle stressful situations
• Work structured, solution oriented and should have an eye for details
• Being responsible, detail oriented, service-minded and reliable in relation to colleagues and stakeholders
Qualification : Bachelors or Masters in Engineering / Pharmacy
Experience : 6-8 years
Location : Bangalore, Karnataka
Industry Type : Pharma
End Date : 30th August, 2021
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