Teva Pharmaceuticals Senior Compliance Specialist in Irvine, California
Senior Compliance Specialist
Date: Dec 5, 2018
Location: Irvine, California, US, 92618
Company: Teva Pharmaceutical Industries Ltd.
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!
This position will be responsible to ensure investigations (customer complaints and deviations), Corrective Action and Preventive Actions (CAPA), and CAPA Effectiveness Review (CAPAER) in a high-volume Aseptic manufacturing and testing facility are compliant to FDA regulations, procedures, and applicable standards in an efficient and effective manner utilizing skills in project management, root cause analysis, and risk-based decision making.
This position will also assist in evaluating deviation incidents and determining if each should be escalated to an investigation. In addition, this position will investigate and write investigations and manage associated processes within the TrackWise system.
Bachelors of Science or Engineering or equivalent related industry experience
A minimum of 6-years experience in the pharmaceutical or regulated industry
Excellent interpersonal and communications skills
Strong organizational and technical writing skills required
Knowledge of regulatory requirements, such as 21 CFR 210&211
Computer literacy required, includes Microsoft Word, Excel, and Access
Statistics and trend analysis
Minimum 8 years direct pharmaceutical industry experience with at least 3 years direct aseptic environment with laboratory, production, engineering or validation 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
Manufacturing Quality Control
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, 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