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

• Review and approval of method validation protocols and reports
• Review and approval of method transfer protocols and reports
• Review and approval of development study protocols and reports
• Review and approval of equipment/instrument calibration and maintenance records
• Review and approval of equipment/instrument validation/qualification documentation
• Review and approval of software validation/qualification documentation
• Review and approval of cleaning validation/verification documentation
• Review and approval of change controls related to SOPs, test methods, specification documents, forms, master batch records, and master packaging records
• Review and approval of test methods, specification documents, SOPs, master batch records, and master packaging records
• Review and approval of executed batch records and executed packaging records
• Review and approval of laboratory test data for raw materials, components, intermediates, and finished products
• Review and approval of stability data and stability summary reports
• Review and approval of environmental monitoring data/reports and associated documentation
• QA release of raw materials, components, and finished product batches
• Creation of new or revision of existing SOPs
• Support regulatory, external, and Teva global audits
• Support the Inspection Readiness Program
• Complete training assignments timely by the due date
• Assist with document number issuance for controlled documents
• Attend assigned meetings and provide updates as needed
• Assist with compiling site metrics, KPIs, and trend reporting
• Review of environmental monitoring charts and associated documentation
• Conduct corporate standards gap assessments
• Support the Vendor Approval Program (review of vendor documentation, QTAs, etc.)
• Train and maintain proficiency with computerized systems (Glorya, Veeva, Studium, IT systems, etc.)
• Perform other activities as assigned by the manager
  
  

Your Experience And Qualifications

• Required undergraduate BA/BS degree in Life Sciences or related field
• A minimum of 3-5 Yrs of experience in Pharmaceutical QA GMP environment
• Equivalent combination of education and/or relevant work experience will be considered
  
  

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.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

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