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CSV Specialist

Date: Feb 11, 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

We are currently looking for a CSV Specialist (12 month fixed term contract) to join us in Runcorn. The CSV Specialist will be an integral member of the CSV department, managing the CSV requirements and execution.

 

This is a key role that will:

  • Manage the Periodic Review Process
  • Perform external audits of vendors from a CSV perspective
  • Establish the validation and compliance strategies and approaches within the site local projects
  • Ensure adherence to Teva Standards and applicable regulatory requirements and practices,
  • Validate manufacturing systems, Laboratory Systems and Business Systems
  • Work under pressure and to strict deadlines
  • Train people if required in CSV
  • Provide weekly updates to the CSV Manager and escalate any issues as they occur
  • Lead on projects as required

Qualifications

Knowledge, Skills and Qualifications required:

  • Specialist knowledge of CSV derived through both practical experience and theoretical studies, within the pharmaceutical / biotechnology industry
  • Excellent understanding of the regulatory expectations relating to CSV
  • A broad understanding of validation principles in general and the GMP expectations as applicable
  • In depth knowledge of GAMP
  • An understanding of Data Integrity in line with recent regulatory expectations
  • Minimum of degree in a relevant discipline, or equivalent
  • Experience of CSV in a pharmaceutical manufacturing environment
  • Working experience with manufacturing systems (i.e. PLC/SCADA), Lab systems and business information systems

Function

Quality

Sub Function

Quality Assurance Methods

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.