Commissioning & Qualification Consultant - Lupin Pharmaceuticals Inc.

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

The consultant, operating under general guidance, will be responsible for the preparation, execution, review, and approval of commissioning and qualification protocols, reports, and assessments related to equipment, facilities, and utilities. Additionally, the role will involve drafting equipment and material specifications, conducting engineering investigations, and addressing issues associated with equipment and facilities.

Key Responsibilities:

The duties listed below provide an overview of the primary responsibilities. The consultant may be required to undertake additional duties as necessary to fulfill the role.

• Author, review, approve, and execute commissioning and qualification documents, including protocols for Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across various equipment, facilities, and utilities.
• Lead and contribute to projects of varying complexity, ensuring timely and successful completion of commissioning and qualification activities. Manage personal time and resources effectively to align with departmental and site goals.
• Coordinate all necessary activities related to the execution of commissioning and qualification deliverables.
• Collect and manage all data obtained during commissioning and qualification, ensuring data integrity for use in Good Manufacturing Practice (GMP) decision-making processes.
• Ensure that the qualified state of systems is maintained, and any impacts are addressed in compliance with Lupin’s policies and procedures.
• Assess the impact of changes to qualified systems and implement best practices in validation to continuously enhance the site's validation program.
• Assist in troubleshooting and resolving deviations or failures identified during the commissioning or qualification of critical equipment, facilities, or utilities, ensuring product quality and patient safety.
• Participate in presenting results to regulatory agencies in collaboration with Lupin Research Inc.

Qualifications

Qualifications and Requirements:

• Associate degree with a minimum of 1 years of relevant experience.
• Strong understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Extensive knowledge of 21 CFR 211, 21 CFR 820, Part 11, and applicable ISO standards.
• Familiarity with ISPE Guidelines is preferable.
• This position requires a minimum understanding of pharmaceutical regulatory standards.

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.

Search Firm Representatives Please Read Carefully 

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

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