Computer Systems Validation Consultant

Overview

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women's health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities

R OLE S UMMARY

The Computer Validation Specialist will ensure computerized systems are in full compliance with regulatory requirements, company policies, and procedures. The role will contribute to the development, execution and review of validation deliverables for computer systems, hardware and software to ensure systems are implemented according to regulatory requirements and are maintained in an ongoing state of quality and control.

This role will be hired through a third-party partner.

E SSENTIAL D UTIES AND R ESPONSIBILITIES

• Prepare, review, and approve various computer validation documents for CSV projects including the following

Regulatory Assessment for determination of GxP and Part 11 relevance

Qualifications

E DUCATION & E XPERIENCE

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran's status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include : standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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