1+ months

QC Senior Compliance Specialist

Irvine, CA 92606
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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

Teva is searching for a QC Senior Compliance Specialist to join our team in Irvine! The QC Sr. Compliance Specialist performs investigations and fulfills the QC technical compliance role as described below:

 

  • Manage compendia updates by reviewing various compendia and presenting proposed changes to a cross-functional site team for in-depth assessment.  Track tasks for on-time implementation of updates.  Manage change controls to implement necessary changes.
  • Support routine and periodic reviews of QC SOPs and specifications and make sure they align with current approved guidelines, pharmacopeias and vendor specifications.
  • Collect, manage and submit department metrics, compile data and write Annual Product Review reports.
  • Work directly with chemists and supervisors to investigate and compile information and data related to Aberrant, OOS, OOT or any unexpected laboratory result(s).
  • Investigate, write, review and manage Laboratory Investigations related to QC-Chemistry with the Investigator role in TrackWise LABINV. Provide technical review and authorship of documents such as QA protocols and reports and test plans.
  • Monitor, update and assist in the specification and investigation, execution and completion of CAPAs on a timely basis. Continuous compliance to cGMP, GLP and compliant documentation of all Procedures. With the Assignee role in TrackWise CAPA, complete assigned CAPAs and track CAPAs completion for the QC department.
  • Assist in setting meaningful and achievable Corrective and Preventive Actions related to QC Chemistry. 
  • Review and Manage Laboratory Investigations and Incident Reports related to off-site (CRO) Chemistry testing. Effectively communicate with QC Chemists, management and off-site CROs to resolve technical issues and aberrant results presented during testing.
  • Identify and implement continuous improvement changes related to laboratory systems, controls, methods and procedures.
  • Assist QC management and Regulatory Compliance during audits (internal and external) and participate in Audits response. Assist with QC data technical reviews.
  • Follow Teva Safety, Health, and Environmental policies and procedures
Qualifications
  • BS degree in chemistry, biology, microbiology, engineering or equivalent required (Chemistry major preferred).
  • Minimum 6+ years direct pharmaceutical industry experience with at least 2 years direct laboratory experience required.
  • 8+ years direct pharmaceutical industry experience with at least 5 years direct laboratory experience preferred
  • Proven understanding of and experience in, and investigative skills to conduct, summarize and complete sound laboratory investigations, including identification of root/probable cause(s).
  • Technical writing experience required.
  • Fluent in 21 CFR parts 210 and 211, part 11 and regulatory guidance as well as profound understanding of how they are applied to regulatory compliance
Function
Quality
Sub Function
Manufacturing Quality Control
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.

Posted: 2019-12-19 Expires: 2020-02-16

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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QC Senior Compliance Specialist

Teva Pharmaceuticals
Irvine, CA 92606

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