Teva Pharmaceuticals USA, Inc.

TSA Specialist II

US-VA-Forest
Requisition #
17-20308
# Positions
1
Category
Manufacturing/Warehouse - Production

Overview

Plan, coordinate, and execute validation activities associated with facilities, utilities, equipment, process and cleaning validation. Prepare validation protocols, analyze data, and prepare validation summary reports.  Perform validation sampling as required. 

Responsibilities

  • Write validation protocols using information gained from technical services, research and development and published references that clearly and succinctly define the test functions to be executed.
  • Monitor processes to ensure strict accordance with documentation.
  • Review and interpret analytical data. Evaluate process issues and determine performance trends, troubleshoot processes.
  • Summarize and evaluate validation findings in a clear, orderly, and succinct manner.
  • Perform validation sampling using standard operating procedures to evaluate process, equipment, facilities, utilities, and/or cleaning process being evaluated.
  • Provide project team support.
  • Coordinate routine validation activities (e.g., SOP’s, Safety and Training).
  • Prepare reports for FDA submissions.
  • Develop and maintain schedules for assigned projects. Issue protocols, conduct the associated activities, and prepare the final report(s).
  • Write and revise SOP’s as deemed appropriate.
  • Perform continual review of procedures in production to assure efficiency.
  • Provide technical support to operations and contractors, as required. Lead project team using good organizational and communication skills to provide Production, R&D, and Technical Services with properly cleaned equipment/facilities/systems for Manufacturing and Packaging.
  • Communicate validation events to all affected departments, including Operations, Quality Control, Quality Assurance and Production Planning.
  • Maintain all validation databases on a weekly basis to ensure that all requirements are correctly reflected and that all projects are tracked appropriately.
  • Organize all validation data and results such that needed information can be accessed quickly and easily.
  • Responsible for the timely completion of all validation activities.
  • Responsible for ensuring that cleaning executions are communicated and completed.
  • Responsible for providing operational support, training, and troubleshooting as required.
  • Manage, lead, and/or assist validation contractors as required.

Qualifications

Education/Certification/Experience:

 

BS degree and a minimum of five (5) years of experience in Validation and/or Technical Services.

 

Skills/Knowledge/Abilities:

 

  • Lyophilization equipment and process experience preferred.
  • Through working knowledge of process, cleaning, equipment, facilities, and computer validation experience preferred.
  • Knowledge of pertinent technical information related to an assigned project.
  • Working knowledge of the operation, maintenance, and utility of all manufacturing and/or packaging equipment for assigned projects.
  • Thorough familiarity with cGMP’s, SOP’s, and relevant government regulations.
  • Ability to identify potential issues, review and judge data, and provide suggestions for improvement.
  • Working knowledge of Microsoft Office applications.
  • Ability to communicate effectively with individuals at all levels of the organization.
  • Ability to write validation protocols and reports.
  • Ability to clearly present data, ideas, and updates on projects at team meetings.
  • Ability to track multiple projects; ability to prioritize multiple urgent tasks while performing daily duties.
  • Ability to identify process problems.
  • Ability to design and execute experiments to troubleshoot issues.

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