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Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Position Summary

Working independently under the supervision of the Sr. Manager, QC laboratory, the incumbent manages and coordinates all activities associated with documentation testing specification, product monographs, and analytical documentation templates and testing records that support Quality Control analytical testing and release in a timely, cost-effective, and compliant manner. In addition, the Technical Writer II administers the corresponding change control system(s) and manages the RTC program.  The incumbent will also set up and manage laboratory GMP-generated documents on a validated electronic document management system

 

• Administer changes to Product Monographs, Testing specifications to meet regulatory (compendia, GMP, cGMP, SOP) and business requirements.
• Create, maintain, and revise testing specifications and monographs to reflect the latest approved/current compendia and house methods, comment pages, and validation certificates before effective dates
• Record and maintain an accurate history of change for all monograph updates and specification updates
• Administer the associated Document Management System (active and archived documents) in a compliant and organized manner
• Assist in the review of compendia updates for each compendia publication.
• Manage the RTC program to meet regulatory (compendia, GMP, cGMP, SOP) and business requirements.
• Manages the RTC program by creating new and maintaining the current reduced testing certificate program according to applicable SOPs and is considered the Subject Matter Expert.

Required Skills

• University Degree or College Diploma in Chemistry or related science
• Minimum of four (4) years of relevant experience in the pharmaceutical industry

Desired Skills

• Knowledge of analytical instrumentation, techniques, and testing
• Good computer skills with proficiency in Microsoft Office and Labware LIMS, SAP, navigating online compendia publications
• Good knowledge of QA business processes & RA business processes. Good understanding of:
  • Analytical methods (USP/NF, BP/EP) and techniques common to QC Lab
  • GMP, cGMP, and other regulatory requirements and compliance regulation
  • Key measurements to support business related to customer service
• Organize yourself and make good use of time to complete tasks and projects
• Ability to handle tasks simultaneously
• Develop work plans considering the departmental objectives, responsibilities, accountabilities, timelines, and resources
• Keep appropriate individuals informed on progress of tasks/projects

Function

Sub Function

Reports To

In process of validation

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