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Group Leader Quality Control

Date:  Jan 25, 2023
Location: 

Forest, Virginia, United States, 24551

Company:  Teva Pharmaceuticals
Job Id:  43714

Who are we?

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!

Job Description

As a Team Leader Quality Control, you will be responsible for leading Quality Control activities. This role provides quality control support for scheduling/auditing of QC testing (inprocess/release/stability), leads personnel, and ensures release of raw material/component timelines are met and inter-departmental support. Functions include personnel development, investigation review/approval, documentation reviews, validation review/support and contract lab support

Communicate directly with the Quality Control Analysts throughout the shift to assist in problem solving while providing quality control guidance.

  • Supervise and schedule the activities of the QC Analysts to assure compliance with cGMP’s and adherence to schedules.
  • Identify improvements/new procedures/ compliance gaps based on applicable regulations.
  • Complete and document laboratory and investigation reports.  Ensure all pertinent information is compiled, reviewed and approved prior to any product disposition.
  • Work with Operation and other business units such as contract laboratories to investigate and troubleshoot all routine problems.
  • Initiate/approve Change controls, review/approve SOPs, and Review/approve methods and specifications, and qualification documents.  
  • Data review/Auditing raw materials/components for production use and periodic reports
  • QC release for raw materials/components for production use
  • QC Planning
  • Laboratory Training and Qualification
  • QC Documentation Management, Issuance and Control
  • Author, review and approve laboratory investigations (as applicable)
  • Cleaning verification testing/data review
  • Sample Management/Tracking
  • Stability Management/Testing
  • Retention Management
  • Third Party Testing – Contract Laboratory Support (EM, Air, Water, etc)
  • APR/PQR
  • Instrument/Software Qualification

Requirements

  • 4-year Bachelor’s Degree within a scientific discipline strongly desired.
  • Minimum 5 years of experience in Quality within a pharmaceutical, food, nutraceutical or related manufacturing environment required.
  • Thorough knowledge of cGMP’s required.
  • Working knowledge of US (FDA) GMP requirements and associated guidelines with ability to increase others knowledge preferred.
  • Experience in administration of quality systems such as LIMS, Wisdom and Trackwise Harmony. 
  • Ability to make independent decisions and take appropriate actions as required.
  • Knowledge of MS Office, including Word and Excel required and ERP system.
  • Ability to read, understand and follow written instructions such as SOPs, methods/specification, cGMPs, etc.
  • Ability to be clear and concise when conveying information, summarizing facts, asking questions, etc.
  • Must effectively work with different departments and communicate with all levels of management.
  • Ability to coordinate several activities at once while ensuring on time releases of raw materials /components and release of testing inprocess product, finished product and stability data.
  • Must work with Planning, Quality Assurance, Production and contract laboratories as needed to ensure proper priorities are set and necessary activities are planned to meet these goals.

Function

Quality

Sub Function

Manufacturing Quality Control

Reports To

Associate Director Quality Assurance - Site Quality Head

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.