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 twelve 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.
ResponsibilitiesThis position is a third-party hire ( Contract ROLE)
Role and Responsibilities
Support in overall management of consumer complaints from the US market, assessment of complaints received from Pharmacies, regulatory agencies, by logging, notifying the respective manufacturing site and in-licensing companies, trending, follow-up with reporter on queries, review of investigation, coordination with outsourced partners.Support in GMP audits of new product development sites, manufacturing and packaging sites, Active Pharmaceutical, excipient vendors, 3PL sites. Support in regulatory reporting of field alert reports to the regulatory agency by thorough review of investigation report, risk assessment reports, supporting documents.Support in management of field actions (recalls) from the US market by accumulation of data / information required for submission, coordination with different teams in obtaining desired information, preparation and review of draft documents, coordination with 3PL for readiness prior to execution, monitoring the process and management of product destructions. Support to in-licensing products and co-marketing projects to provide oversight of Quality Management Systems such as batch record review, out of specifications, deviations, change controls, CAPAs and batch release.Support to logistics activities such as review of work instructions, quarantine notification, transit damage and follow-up with manufacturing sites, case labels, pallet labels, destruction request, product returns, and customer queries.Support in preparation and review of Quality Agreements for new products with contract manufacturers, contract packagers, contract analytical sites, distribution partners etc. Ongoing review and improvement of Standard Template of Quality Agreement in accordance with the changes in regulatory guidance’s and expectationComputer skills: proficient with Word, Excel, PowerPoint, and Adobe Acrobat QualificationsQualifications and Education Requirements
Bachelor’s / Master’s degree in science with 4-5 years’ experience in managing Quality Assurance activities for pharmaceutical quality systems. Previous Quality Assurance experience preferredStrong to excellent technical writing, editing skills and verbal communicationFlexible and adaptable when learning new thingsStrong organization skills with attention to detail and accuracyAble to work within tight deadlinesMust be an effective verbal and written communicator with proven abilities to communicate complex information and concepts with clarity.Strong to excellent organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detailAbility to work independently and in a team oriented environment
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
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.