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Quality Engineer - Laboratory, Generics/Specialty/EU

Date: Jan 30, 2019

Location: Runcorn, GB, WA7 3FA

Company: Teva Pharmaceuticals

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/Senior Quality Engineer works with local and international R&D product development teams to ensure compliance to the Quality Management System (QMS) for drug injection delivery system product concept through industrialization and commercial life cycle management.  The position has review and approval authority on project documentation in coordination with internal and external business partners.  This includes, but is not limited to: project design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, risk management activities, change controls and other documentation.  The incumbent assures that project output meets combination product regulatory requirements.  This position assists in the development and implementation of site/WW QMS GMP policies and procedures.  Additional responsibilities will ensure departmental compliance in generating and maintaining design control files (DHF’s, DMR’s).  The position also provides R&D Quality support to assure RN SDT laboratory operations are compliant to the QMS.  This includes compliance to laboratory related activities such as but not limited to: RLD characterization, device design verification and validation, method development/transfer, 3rd party laboratory compliance, laboratory records. 

Key Results Areas

  • Provide quality compliance support for local and satellite design and development teams as required.  Review and approval authority on project documentation in partnership with internal business partners and external business partners. (product design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, change controls and other documentation) to confirm that the output meets combination product regulatory requirements. 
  • Actively participates in the development/maintenance of the R&D Quality Management System (QMS) in support of design control development of drug injection devices.
  • 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.
  • Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports 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 as required.
  • Communicate with management on device development status.
  • Actively participate in the further development of the UK site QMS with emphasis on laboratory operations and laboratory Data Integrity
  • Providing Project Management support as needed for multiple testing projects.Ensure project documentation is produced and reviewed within agreed timelines to achieve business goals

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
  • Proven participation and/or experience contributing project experience of a diverse team, especially in a multi-sites environment
  • FMEA / risk analysis experience highly desirable.
  • Intimate understanding of how quality management systems operate.
  • Able to travel long distances if required, including extensive air travel

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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