Quality Sr Specialist

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• Responsible for Collection, compilation, analysis, and review of all data for APQR.
• Responsible for Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. 
• Responsible for Review/approval of all documentation associated with the process validation ,CPV & cleaning validation.
• Responsible for processing of documents through the generation, modification, review, and approval and archival of records.
• Responsible for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Responsible for tracking, trending, and reporting of Quality Metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
• Responsible for Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
• Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. 
• Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations.
• Responsible for Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.
• Responsible for Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and/or the utilities associated with the site.

Your experience and qualifications

• B.sc/Msc in chemistry
• 4 to 10 years of experience
   

Reports To

Manager Quality Systems

Teva’s Equal Employment Opportunity Commitment

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success.  Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14  sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.