Deviation, Validation & Change Request Professional | Novo Nordisk | Bangalore

Job Description

Department – Operation Quality Consulting & Projects (OQCP)

The position:

As an Advanced Quality Professional II, you will be providing compliance support to International Operations (IO) and North America Operations (NAO). Furthermore, you will support Deviation, Validation, and Change Request (CR) handling set-up fit for purpose in IO and NAO and perform Department specific tasks. Additionally, you will support 80+ countries virtually. 

You are entrusted to fulfill the following responsibilities:

• Provide compliance support with a focus on End-to-End handling of Deviations, Change Requests, and Qualification of Cold chain equipment.
• Collaborate and coordinate with OQCP/headquarter (HQ) specialist(s) to provide timely compliance support to Deviations, cold chain validation activities, and CR handling to IO and NAO.
• Development, implementation, maintenance, and continuous improvement of the Deviations, cold chain validation setup, and CR handling in IO and NAO.
• Provide timely, specific, and Quality support to Deviations, Qualification, and CRs.
• Help the team in improvement projects within Deviations, cold chain validation, CR handling, and other relevant processes and necessary reporting to Management in OQCP/Operations & Staffs Quality (OSQ) as requested.

Qualifications:

• University/equivalent degree (Pharmacy, Biology, Chemistry, or similar).
• Overall, 4 to 6 years of experience working in a Global Pharmaceutical Company.
• Work experience in the pharmaceutical industry.
• Hands-on experience in end-to-end handling of Deviations and Change control.
• Trained and worked according to international validation principles.
• Experience with Change Request handling.
• Experience with GMP/GDP on the operational level.
• Intercultural experience.
• Good interpersonal skills and Professional authority.
• Good communication skills in talking to people at all levels of the organization.
• Good analytical skills, including the ability to apply a risk-based approach.

About the department

OQCP (Operations Quality Consulting and Projects) team is an extended unit from Denmark that supports 80+ affiliates and staff areas across Novo Nordisk. At OQCP, we focus on business-critical issues that may have an impact on NN license to operate and inspection readiness by providing high-quality services through regular contact, connection, and interaction with our affiliates at all levels. As part of the OQCP team, you will support the implementation/maintenance of the Novo Nordisk Quality Management System in affiliates and staff functions.

Apply on or Before 28th April 2023