Lupin Pharmaceuticals (Company Headquarters)

  • Technical Writer, Production

    Posted Date 3 weeks ago(11/27/2018 1:39 PM)
    ID
    2018-2435
    # of Openings
    2
    Category
    Packaging
  • 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 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.

    Responsibilities

    The Technical Writers in Production work as a team and report to the Lead Technical Writer. The primary responsibilities of the Technical Writers in Production are to prepare and maintain detailed Manufacturing Batch Records (MBR’s), Packaging Batch Records (PBR’s), Standard Operating Procedures (SOP’s), Investigations, protocols and reports. New documents will be developed based on input from Product Development, Operations, Validation, Quality and Project Management. Revisions will be maintained based on detailed and specific changes to the original document as requested by the above departments.  The Technical Writer will ensure all documentation activities are carried out in compliance with regulatory requirements, Good Manufacturing practices (cGMP) and standard operations procedures.

    • Creation and revision of batch records and SAP recipes for manufacturing and packaging of an array of products including tablets, capsules, liquids, suspensions, and powders
    • Creation and revision of batch records and Standard Operating Procedures (SOP’s)
    • Provide recommendations on packaging materials selection, suppliers
    • Calculate theoretical weights for sales from the SKU to the pallet level Manage and control manufacturing documents during multiple revisions, ensuring accuracy of the original documents and the integrated changes.
    • Prepare and ensure readiness for packaging of new product launches 
    • Implement system for palletization of pallets on packaging line including CAPE PAK diagrams in batch records
    • Coordinate studies for child resistance and develop new packaging solutions to achieve required security
    • Creation of exhibit batch records for initiation of stability for the introduction of new packaging materials
    • Selection, confirmation and implementation of packaging materials (bottles, caps, labels, shippers, cartons, blistering materials) for new packs as well as comparisons with existing materials equivalency 
    • Draft and execute protocols to test new packaging materials on existing lines and initiate stability 
    • Create and execute change controls 
    • Work with third parties to coordinate packaging activities including review and approval of records
    • Draft and execute protocols for packaging line trials or product rework
    • Work with several departments including QA/QC, Production, Marketing, Sales, Regulatory, Purchasing, and Planning on a daily basis in a GXP environment
    • Collaborate with SME’s to capture best practices and accurate documentation.
    • Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, terminology and SOP’s.
    • Maintain records and files of work and revisions.
    • Recommends changes to the process to enhance efficiencies and improve current processes.
    • Become familiar with production processes and methods by building productive relationships with production, engineering, validation and development personnel.
    • Observe production, developmental, and experimental activities to understand detailed operating procedures and methods to create effective manufacturing documents.
    • Train or assist in the training of new hires.
    • Other duties as assigned

    Qualifications

    • Bachelor’s Degree in an engineering or scientific field
    • 1 – 2 years of pharmaceutical packaging operations experience preferred
    • Knowledge of cGMP environment
    • Strong communication and technical writing skills
    • Effective and results-based achievement in fast-paced, customer service, deadline driven and multi-project environment

     

    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 10 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed