Teva Pharmaceuticals Quality Investigator in Irvine, California
Date: Mar 13, 2019
Location: Irvine, California, US, 92602
Company: Teva Pharmaceuticals
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. 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.Join us on our journey of growth!For more on Teva, check us out at www.tevapharm.com at http://www.tevapharm.com/ or www.tevausa.com at http://www.tevausa.com/ .
Personnel in this position will be reviewing investigations as described below:
Review and closure of Production, Maintenance, Engineering, Quality Control investigations.
Review and approval of QC Microbiology environmental monitoring investigations
Provide feedback and train to others on how to write Deviation Reports (DR)
Conducting Complaint investigations (as needed)
Creating and monitoring the execution of Corrective and Preventive Actions.
This position is responsible for (in discussion witth senior investigators/management, if necessary) evaluating deviation incidences and determining if each should be escalated to an investigation. The Quality Investigator will work with Production and other departments as needed, authoring the deviation report and creating and monitoring the execution of CAPAs through TrackWise, as well as making recommendations for batch disposition in process.
Essential Duties & Responsibilities Percentage of Time
With the QA role in TrackWise, monitor and review all Laboratory Investigations
Review incident and deivation investigations . Recommend corrective and preventive actions.
Train and counsel production, facility, maintenance and engineering personnel to better identify, document and define events, their need for expedient identification, the need to stop and quarantine as necessary and the need for immediate notification to the Quality Department to minimize risk.
With the QA role in TrackWise CAPA, identify, create and follow up on completion of CAPAs.
Write or revise SOPs as needed
BS degree in chemistry, biology, microbiology or engineering or equivalent related industry experience
Minimum 4 years direct pharmaceutical industry experience with at least 3 years direct laboratory, engineering, production or validation experience.
Minimum 6 years direct pharmaceutical industry experience with at least 4 years direct laboratory, production, engineering or validation experience, and 2-4 years of Quality Assurance experience.
Specialized or Technical Knowledge Licenses, Certifications needed:
Fluent in 21 CFR parts 210 and 211, part 11 and regulatory guidances as well as profound understanding of how they are applied to regulatory compliance
Senior Manager Compliance
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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Irvine California
Nearest Secondary Market: Los Angeles
EOE including disability/veteran