15 days old

Change Control Analyst

Irvine, CA 92606
Company Info

If youre like people at Teva, you dare to be different. Were making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.
Tevas Irvine, CA production site is one of our complex manufacturing and supply chain operations.
We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success.  Be part of it!

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance

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

Teva is searching for a Change Control Analyst (Quality Systems) to join our team in Irvine, CA!

This position is primarily responsible for supporting the change control within the quality systems organization with focus on QA review and processing of document changes and change controls within the Electronic Document Management Systems (EDMS) and TrackWise system. Additionally, will be Subject Master Expert of the computer systems support Change Control such as EDMS and TrackWise.

You will:

  • Provide quality oversight to the change management system for complex Minor and/or Major Change Controls of documents, processes, Equipment and systems including managing communication with 3rd party clients pre and post implementation on applicable change controls.
  • Verify that proposed changes adhere to local SOPs and 21 CFR parts 210 and 211 as well as Part 820 requirements while leveraging ICH Q9 and Q10 and ensuring escalation of potential issues to Teva management/ third party liaisons.
  • Ensure the health of these systems minimally meet the KPI metrics established by the global team and site leadership by routinely monitoring and managing corrective actions when needed.
  • Become SME for EDMS (TevaDoc and Wisdom) and TrackWise for change control.
  • Serve as back-up SME for other elements within the sites quality systems such as LIMS and SAP.
  • Draft new, and revise existing procedures to ensure implementation of continuous improvements/compliance changes related to quality systems processes.
  • Participate in inspection readiness activities, investigations and internal audits with potential to lead investigations.
  • Recognize opportunities for improvement and drive change through collaboration and influencing stakeholders outside quality department and implements continuous improvement efforts as they relate to QA.
  • Solicit information from various departments and compile PowerPoint presentation for routine quality systems meetings.
  • Provide employee training for document change and change control processes.
  • Provide guidance to change control owners in all GMP areas to ensure compliance with all applicable procedures / regulations and assists in resolution of issues identified.
  • Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Batch Record instructions.
Qualifications
  • Bachelors degree in Science or Engineering related subject required.
  • ASQ Certification preferred.
  • Minimum of Four years related QA experience in a Pharmaceutical manufacturing environment is required.
  • Experience working in a Sterile Aseptic manufacturing environment strongly preferred.
  • Experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements related to production of pharmaceutical products and associated quality systems preferred.
  • Experience with and in-depth knowledge of document changes and change control process required.
  • Experience with Manufacturing/Quality systems such as TrackWise EDMS and SAP preferred.
  • Statistical software JMP or Minitab a plus.
  • MS Office experience required. Experience performing data analysis using MS Excel is preferred.
Function
Quality
Sub Function
Documentation Life Cycle
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.

Categories

Posted: 2020-10-06 Expires: 2020-11-06

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Change Control Analyst

Teva Pharmaceuticals
Irvine, CA 92606

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