Job details
Job type full-time
Full job description
Company info
If you’re like people at teva, you dare to be differentWe’re making well-being a way of life for our customers and our colleaguesJoin us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.
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 worldwideOur 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 dayWe offer a uniquely diverse portfolio of products and solutions for patients and we`ve built a promising pipeline centered around our core therapeutic areasWe 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 innovationThis is how we improve health and enable people to live better, healthier livesJoin us on our journey of growth!
We offer a competitive benefits package including medical, dental, vision and prescription coverage starting on the first dayWe also offer disability and life insurance, paid time off, 6% match on the 401(k), employee stock purchase plan and tuition assistance
Job description
Will perform gxp audits of pharmaceutical manufacturing, packaging/ labeling, laboratory controls, technical services, storage & distribution and quality systems for sterile/non-sterile apis, drug products, medical devices, combination products, packaging materials and servicesGxp audits are normally taken place in the americas region on behalf of teva sites and business partners worldwideThey are scheduled, prepared, conducted and followed up by the auditor based on teva’s annual audit work plan and agreed gmp standardsScope of the position includes external vendor audits and internal global risk assessment (gra) audits of teva sites, however the primary focus will be teva’s external vendorsThe scope also includes participating in process improvement projects and initiatives to continue to strengthen the global audit organization.
Key responsibilities
Scheduling, preparation, conduct, documentation and follow-up of assigned gxp audits in accordance with teva corporate standards
Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory gmp requirements and specific teva requirements
Communication to stakeholders on potential risk and product impact from observations and gmp deficiencies found during your audits
Provide support to teva site with supplier qualification issues and supplier risk assessment based on audit result when required/requested
Support notification to management process in case of critical audit findings in collaboration with audit regional lead and audit plan owner
Regular participation in gmp trainings (internal/external)
Must be able to travel approximately 50% -both domestic and international
**this is a remote position - can sit anywhere in the us**
Qualifications
Undergraduate/bsc degree in applicable discipline required
7+ years` of experience required as a quality auditor in a regulated pharmaceutical environment
Minimum of 50 audits performed in a lead auditor role
Knowledge, skills and abilities:
Uses best practices and knowledge of internal or external business issues to improve products/services or processes
Typically resolves complex problems or problems where precedent may not exist, takes a new perspective using existing solutions
Participates in project teams
Acts as a resource for colleagues with less experience
Requires in-depth knowledge and experience of audit management and execution
Works independently; receives minimal guidance
Strong working knowledge of current good manufacturing practices (cgmp), food and drug administration (fda), the rules governing medicinal products in the european union, who and other regulatory requirements
Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
Function
Quality
Sub function
Supplier quality
Reports to
Dir quality global audits, regulatory compliance
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 priorityYou will also be able to see opportunities that are open exclusively to teva employeesUse the following link to search and apply: internal career site
The internal career site is available from your home network as wellIf 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 employmentIt 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 lawsWe are committed to a diverse and inclusive workplace for allIf you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection processAll accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Job type: full-time
Work location: multiple locations
