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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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QC Validation Area Specialist II - Computer Systems Job

Date: Dec 5, 2018

Location: Clayton, NC, US

Company: Novo Nordisk

Your Groundbreaking Journey

At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose:
Oversee the local laboratory validation program for software. Plan, manage, & perform laboratory validation activities on software solutions used in the laboratories. Ensure software is compliant with applicable regulations (e.g. 21CFR Part 11, etc.). Routine review of applicable IT & laboratory validation procedures & completed validation protocols for accuracy, completeness, & maintenance of validated state per corporate requirements & industry requirements.

Accountabilities:

  • Accuracy & compliance of software validation records

  • Validation of laboratory software

  • Metrology

  • Software Validation process SME for QC areas

  • Change control

  • Other duties, as assigned

REQUIRED QUALIFICATIONS:

  • Minimum of five (5) years of chemistry, laboratory validation, or engineering experience required. Pharmaceutical experience preferred.

  • BS/BA Degree in Engineering, Chemistry, Life Sciences

DESIRED QUALIFICATIONS:

  • Minimum of three (3) years of software validation (CSV) experience.

  • Experience with writing & executing validation protocols.

  • Experience with managing projects.

  • Experience with software lifecycle management.

  • Experience participating in regulatory audits & expert knowledge in the interpretation & application of relevant Domestic & International Regulations & Industry Standards (e.g. cGMPs, USP/EP/JP, ISO, QSR, GAMP5, 21CFR11, Computer System Validation, etc.).

  • Demonstrated ability to write technical & scientific documents & reports.

  • Demonstrated ability to present technical & scientific information to others at all levels.

  • Demonstrated ability to manage multiple projects & competing priorities.

PHYSICAL AND OTHER REQUIREMENTS:

  • Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility.

  • Constantly operates a computer & other office equipment using hands.

  • Able to work in an open office environment with the possibility of frequent distraction.

  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The sourcing period for this role will end 19 December 2018.

Requisition ID: 59234BR
State/Provinces: Clayton
Job Category: Quality


Nearest Major Market: Raleigh

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