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Global Quality Auditor
4 months ago
Who We Are?
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
We're currently recruiting for a Global Quality Auditor to join our team on a full time, permanent basis working fully remotely from anywhere across Europe.
A Day In The Life Of A Global Quality Auditor
You'll be performing 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 services.
GxP audits are normally taken place in Europe and Israel on behalf of Teva sites and business partners worldwide. They are scheduled, prepared, conducted and followed up by the auditor based on Teva's annual audit work plan and agreed GMP standards.
Scope 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 internal Global Risk Assessment audits and Teva's critical CMO vendors. The scope also includes insuring Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches. In addition leading and 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 domestically and internationally
Who We Are Looking For
Do you have?
- Undergraduate/BSc degree in applicable discipline required
- Minimum 7 years of experience required as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 50 audits performed in a Lead Auditor role
- Medical Device or Sterile Manufacturing Expertise would be desirable
- 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 with a regulatory authority, e.g., FDA/EU is preferred but not required
- Fluency in written and spoken English
- Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
Are you?
- Able to interpret internal or external business issues and recommend solutions/best practices
- A complex problem solver that takes a broad perspective to identify solutions
- Open to working independently, with guidance in only the most complex situations
- An effective presenter who can convey a clear message through excellent written & verbal communications and interpersonal skills
If so - we would love to hear from you
Function
Quality
Sub Function
Quality 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 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.
The deadline for internal application will close on Tuesday 4th April 2023 #TJ
Teva's Equal Employment Opportunity Commitment
At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.
Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That is why we are constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice.
