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Quality Engineer - Laboratory, Generics/Specialty/EU

Date: Dec 3, 2018

Location: Runcorn, GB, WA7 3FA

Company: Teva Pharmaceutical Industries Ltd.

Company Info

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

The Quality Engineer (Labaratory) provides primary R&D quality support to the RN SDT laboratory operations.  The incumbent assures compliance to R&D Quality QMS is maintained in all laboratory related activities including but not limited to: RLD characterization, device design verification and validation, method development, method transfer, 3rd party laboratory compliance, laboratory records, calibrations, equipment PM.  As a Quality Engineer you will  work with local and WW product development teams as needed to ensure compliance to the projects from product concept through industrialization and post market support

 

Main responsibilities:

 

  • Assure the compilation and management of all laboratory documentation in accordance with R&D Device QMS and Teva CORP standards.  
  • Work with R&D staff and business partners (contract laboratories, CMO’s, CDO’s) in solving complex quality compliance issues affecting laboratory operations and device components/assembly quality.
  • Provide primary Quality support for tech transfer including support in drafting, review, execution, and approval of protocols and reports.
  • Manage and assure that necessary project development contact and support is maintained with relevant business partners and Teva site teams
  • Provide guidance and primary Quality review support for Design Verification/Validation activities.
  • Represent Teva R&D Quality in design decisions with business partners.
  • Support agreements (QTA’s and business development agreements) with laboratory service providers.  Assure that the content of the agreements meets QMS requirements and is within expected regulatory guidelines. 
  • Identify, recommend, communicate, and assure follow-up compliance and surveillance with laboratory business partners in CAPA’s.
  • Provide advice, review, and evaluation of SDT QMS controlling protocols and final reporting.    
  • Perform audits onsite and offsite at laboratory service suppliers.
  • Communicate with management on device development status.
  • Actively participate in the further development of the UK site QMS with particular emphasis on laboratory operations and laboratory Data Integrity.
  • Compiling, writing, and review of training material and conducting training sessions on quality protocols related to the laboratory

Qualifications

  • Degree in science, engineering, or technical field
  • Background in mechanical engineering preferred
  • Experience working in a medical device testing and development laboratory
  • Experience in advanced statistical models and methodology
  • Experience in the medical device and/or combination products field
  • Working experience in the medical devices, combination products, or other FDA regulated (GMP) industry
  • Experience in assuring Data Integrity (DI) is achieved and maintained
  • Mechanical testing/automated equipment experience is highly desirable
  • Medical device/combination product industrial experience is highly desirable
  • Injection molding experience is highly desirable
  • Previous experience on a design development team is highly desirable
  • Working knowledge of Device regulations (FDA 21 CFR820, ISO 13485 and other ISO standards relating to drug injection systems, EU Medical Device Directive, ASTM, ANSI)
  • Working knowledge of medical device regulatory requirements (US, Canada and Europe) highly desirable
  • Knowledge of Data Integrity compliance

 

 

Function

Quality

Sub Function

R&D Quality

Reports To

In process of validation

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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