What are the responsibilities and job description for the CONTRACT - BATCH RECORD REVIEWER position at 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 womens 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 :
Role and Responsibilities
This is a short-term contract position ( Monday - Friday 8am - 5pm)
The Batch Record Reviewer will report to the Associate Director of Quality Assurance and will work cross-functionally within the Production, Packaging, and Product Development departments to review Master Batch Records and Completed Batch Records. The Reviewer will ensure all work is performed and documented according to approved Standard Operating Procedures, in general compliance with cGMP by reviewing batches and cross-checking against specifications. The Reviewer will also perform in-process data reviews. Working in a timely manner is imperative. Partner with project management, supply chain, QA, and QC to effectively plan and execute all projects in manufacturing
- Review batch records; cross-check against specifications for accuracy, completeness, and to identify any potential issues
- Upon identification of variances, notify proper department Supervisors
- Prepare department-specific metrics for management review.
- Review proposed Manufacturing and Packaging batch records.
- Perform data entry activities for department databases and / or logbooks.
- Assist in compiling data for annual product review.
- Cross train on in process quality activities.
Qualifications :
Qualifications and Education Requirements
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, veterans 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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