Quality Assurance Auditor III

Teva Pharmaceutical Industries Parsippany , NJ 07054

Posted 3 months ago

Company Info

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!

Job Description

The Global Quality Auditor performs GMP/GDP 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.

GMP/GDP audits are normally taken place in the Americas 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.

The scope of the position includes external Vendor audits and internal Corporate Quality audits of Teva sites. In addition, this position will have responsibilities to ensure our Teva sites have robust inspection readiness plans in place to ensure smooth regulatory agency inspections and successful product launches.

Travel Requirements

Essential Duties and Responsibilities

Scheduling, preparation, conduct, documentation and follow-up of assigned GMP/GDP audits in accordance with Teva corporate standards

Initial assessment of audit deficiencies, corrective and preventive actions, and overall site compliance status based on regulatory GMP requirements and specific Teva requirements

Support of requesting Teva site with supplier qualification issues and supplier risk assessment based on audit result when required

Support of notification to management process in case of critical audit findings in collaboration with audit hub manager and audit plan owner

Regular participation in GMP trainings (internal/external)

Application of electronic audit database and audit workflow system for the documentation of audits

Readiness to travel at least within the Americas for audit purposes in due consideration of Teva's business travel global policy.

Qualifications

Required education: Bachelors in Scientific Discipline, preferred Masters in Scientific Discipline

Experience Required: At least 5-7 years experience as a Quality Auditor, with at least 75 audits performed as a Lead Auditor

Preferred experience: At least 5-7 years experience as a Quality Auditor, with at least 80-100 audits performed as a Lead Auditor. Previous experience with a regulatory authority (FDA)

Additional competencies:

Has sufficient experience in pharmaceutical production, QA or QC, or combined experience, familiar with international GMP regulations and guidelines

Style, tone and language need to be consistent with standard business English

Prepare technical/complex written materials that are accurate, clear, logical, well organized and contain proper grammar, punctuations and spelling

Can perform independent and objective decision making during audits

Strong communication skills, must be able to review, interpret and discuss pharmaceutical regulations and their current application.

Can be in constant improvement by self-study, be sensitive to details (should be scrupulous)

Function

Quality

Sub Function

Quality Compliance

Reports To

Director Quality Global Audits

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: New York City

Nearest Secondary Market: Newark



See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Spring 2019 Internship Quality Assurance

ADP

Posted 2 months ago

VIEW JOBS 11/3/2018 12:00:00 AM 2019-02-01T00:00 ADP is hiring a Quality Assurance spring intern to join the Product Development team. In this position you will contribute to project-based deliverables aligned to your field of study. You will interact with professionals who will guide and support you as you enhance your skills while gaining relevant experience. Projects will involve test coverage plans, test automation, data validation, and building SME to be the first line of defense in support of production defect triage. REQUIREMENTS: * Must be eligible to work part-time during Spring 2019 semester * May 2020 or December 2019 grad * Completing a bachelor's or graduate degree in Computer Science, Computer Engineering, or equivalent area of study * Knowledge in programming & scripting languages such as Java, HTML/CSS, JavaScript, Python * Must be able to run SQL freely and understand database structures and procedures PREFERRED QUALIFICATIONS:Preference will be given to candidates who have the following qualifications: * Excellent communication (verbal, written and reporting) skills * Able to demonstrate attention to detail, superb organizational and follow up skills * Critical thinking and an analytical mindset Software in the Cloud. Experts on the Ground: ADP powers the working world with comprehensive solutions that drive business success. Consistently named one of the "Most Admired Companies" by FORTUNE® Magazine, and recognized by Forbes® as one of "The World's Most Innovative Companies," ADP has over a half-million clients around the globe and 65 years of experience as one of the largest providers of human capital management solutions world-wide. At ADP, we believe that diversity fuels innovation. ADP is committed to equal employment opportunities regardless of race, color, genetic information, creed, religion, sex, sexual orientation, gender identity, lawful alien status, national origin, age, marital status, or protected veteran status. We support an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. ADP Parsippany NJ

Quality Assurance Auditor III

Teva Pharmaceutical Industries