Lupin Pharmaceuticals (Company Headquarters)

  • Technical Writer, Tech Transfer

    Posted Date 4 weeks ago(9/18/2018 1:10 PM)
    ID
    2018-2393
    # of Openings
    1
    Category
    R&D
  • Overview

    The Technical Transfer department works to take Research and Development concepts into working production to manufacture drugs of various dosage forms and therapeutic areas.  The Technical Writer is responsible for the coordination, preparation and maintenance of scientific reports once these Research and Development concepts begin to undergo testing on a commercial scale.  Training will be provided.  The writer is responsible for writing and editing master formulas, product development reports, tech transfer reports, Scale up reports, standard operating procedures and any other technical documents. Technical responsibility for interpreting, organizing, executing and coordinating experimentation related to development /scale up/ tech transfer projects.  

     

            

     

     

     

     

      

    Responsibilities

    • Support Technical operations department by analyzing data and providing conclusions as part of technical reports.
    • Maintain and organize Technical operations documents.
    • Responsibilities will also include performing investigations and other compliance related tasks (FDA and DEA).
    • Perform audit functions as necessary such as notebook review or controlled substance documentation.
    • Assist in preparation and review of controlled documents to ensure accuracy of data and content which include: Change control, Master production records, Master packaging records, validation summary reports, Product Launch Updates, Technology transfer report, Investigation Reports, Process optimization Reports, Validation Protocols/report and Standard Operating Procedures (SOPs) etc. Maintain electronic version of control document in computer system.
    • Coordinate with Pharmaceutical Development Scientists / Technical operation scientist to prepare master formulas that depict the process to produce pharmaceuticals.
    • Collaborate with Regulatory Affairs to provide documents to obtain approval of pharmaceutical products with the
    • Responsible for maintaining Product Development / Technical operations documents so they are readily accessible.
    • The Technical writer will work closely with Quality Assurance performing investigations to related products.

     

    Qualifications

    • Associate (Bachelors preferred) degree in a scientific discipline.
    • Must have excellent grammatical skills and effective oral and written communication skills.

    • Adaptable to changes in work duties, responsibilities, and requirements and can manage work load.
    • Strong interpersonal skills; capability to work as part of a team with formulation scientists and other departments.
    • Detail-oriented, thorough and methodical, and excellent organizational and planning skills with ability to manage and prioritize multiple tasks while still meeting deadlines. Possesses good editorial/proofreading skills and understands and performs well the process of writing (outlining, drafting, revising, and reviewing).
    • Excellent organizational skills.
    • Able to perform numerous simple and complex tasks without losing sight of overall objectives. 
    • A strong understanding of Word and Excel is critical.

    • Position requires proficient personal computer skills including electronic mail; record keeping, routine database activity, word processing, spreadsheet and graphics.

     

    Physical Requirements

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position requires the ability to occasionally lift office products and supplies, up to 15 pounds. Sitting for long periods of time may be required. Work is performed in an office 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