• Manager, Quality Systems (Documentation and Training)

    Job Locations US-MA-Bedford
    Posted Date 4 weeks ago(4 weeks ago)
    Job ID
    2018-1098
    # of Openings
    1
    Category
    Quality
  • Overview

    This position will be responsible for the development and maintenance of document management systems in terms of applicable regulations and industry practices.  Responsible for developing and implementing procedures and practices for archiving completed batch records, and related controlled documentation.  Responsible for establishing and implementing training program for all employees supporting GXP operations.

    Responsibilities

    •Establish and maintain an electronic document management system compliant with regulatory, and quality requirements
    •Provide Document Control support including but not limited to processing, publishing, and distributing controlled documents
    •Collaborate with cross-functional departments to ensure timely implementation of change requests
    •Ensure timely release of documentation for production process and associated activities.
    •Interact with all departments to develop and implement functional documents as part of functional SOPs initiative (or a Quality Improvement Plan project)
    •Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures
    •Establish and maintain records management system including secure storage, retrieval, retention and destruction
    •Maintain and improve the existing training program. Ensure the training program is extended to GXP operations. Work with all departments supporting GXP operations to establish departmental training modules
    •Within Master Control, develop and design document templates for SOPs, Test Methods, Specifications, Reports, and Protocols preferably in eCTD format. Evaluate capabilities of Master Control and assess if improvements are necessary to maintain compliance
    •Provide new hires an introduction to Quality System as part of New Employee Orientation.
    •Assist in the maintenance of regulatory documents as necessary. If regulatory documents are paper based, assist in transition of eCTD format
    •Supports audits (internal, external, third party) in order to verify that regulatory and quality requirements have been met

    Qualifications

    •Well-organized and detailed oriented professional, with strong verbal and written communication skills
    •Proficient computer skills with working knowledge of MS office such as Word and Excel, Access, Adobe Acrobat professional, and SharePoint
    •Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines
    •Experience with electronic document management system and electronic signatures is required
    •Bachelor’s degree in scientific discipline is required; 8+ years of experience in pharmaceutical industry; with 5+ years of experience in managing document management function and an electronic document management system such as Documentum, Master Control or equivalent

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