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Teva Pharmaceuticals Quality and Compliance Engineering SME in Petah Tiqwa, Israel
Quality and Compliance Engineering SME
Date: Oct 1, 2020
Location: Petah Tiqwa, IL, 1111
Company: Teva Pharmaceuticals
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!
SKILLS NEEDED TO PERFORM THE JOB:
Global Engineering (GE) Quality and Compliance SME will serve as Teva’s focal point for quality and compliance aspects related to engineering processes, manufacturing equipment and systems.
In corporation with Global Quality and EHS will lead the development and implementation of Teva’s policies and standards related to manufacturing equipment and systems throughout their lifecycle.
The Quality and Compliance SME will interface with the different manufacturing segments and sites as well as GE Segments BP, supporting them in the implementation of Teva’s engineering policies and standards.
Lead and participate in quality and compliance sites audits related to engineering aspects.
Work with Global Quality and EHS to develop, revise and enhance various policies and standard operating procedures (SOPs) in accordance with cGMP, FDA CFR Title 21 Parts 210-211, EU commission and ISO regulatory standards.
Ensure Teva’s scope and content of engineering quality and compliance policies such as maintenance, calibration, validation, facilities equipment and utilities are in accordance with industry best practices and guidelines (e.g, ISPE).
Standardize the approach, methodology and templates for equipment and systems validation, installation, qualification, calibration and maintenance.
Cooperate and align with the GE Segments BP for site implementation of the different engineering quality policies, standards, processes and programs.
As needed, review and approve engineering documents for relevancy, clarity, proper specifications, tolerances, dispositions, and GDP (Good Documentation Practice).
Support investigations of non-conformance/deviations (out-of-tolerance and out-of-specification), risk assessments, CAPAs, change controls, and root-cause analysis activities at the segment and site level.
Manage local and global stakeholder interfaces (e.g., SC, QA, EHS, HR, Finance), to ensure GE regulatory and compliance processes are in alignment and creates synergy with other business processes throughout the organization.
As needed, develop content and training materials / processes to enhance local sites engineering team quality and compliance understanding and knowledge.
Participate in a mockup / risk assessments audits related to quality and compliance focusing on engineering asspects
Provide support and guidance to sites during regulatory audits when specific / related issues are raised
Understand and track external and internal development within the area of engineering quality and compliance including regulatory, environmental, technology trends and changes.
Prepare periodic reports for upper management in relation to engineering quality and compliance status
Take part in internal unit projects, as well as creating processes and global guidelines (as required).
Education: B.A / Bsc. degree in Engineering (Mechanical / Electrical / Chemical / Industrial) and / or M.A / Msc. degree in Engineering – Must
Experience in the pharmaceutical/chemical industry – Must
Experience: 10+ year within quality or engineering support and management functions (facility quality assurance, calibration / metrology, validation / qualification) within FDA, EU commission, ISO regulated industries – Must
Knowledgeable and good familiarity with FDA/CFR Title 21 Parts 11, 210-211,820, cGMP/GDP, ISO (14644, 9001, 13485, 17025) and other various regulatory standards - Must
Experience in global, large, complex, multi-level organizational interfaces – Must
Excellent understanding of global function role and the interrelationships with the local manufacturing sites – Must
Global, multinational experience – Advantage LANGUAGES:Fluent in English. Additional languages advantage.
SKILLS NEEDED TO PERFORM THE JOB:
Demonstrated communication skills, both verbal and written
Ability to influence audiences, and lead change management while setting clear business objectives.
Demonstrated leadership and strong interpersonal skills including cross-functional teamwork.
Ability to communicate and present to top management, while translate vision and goals into work plan to be implement worldwide
Ability to be flexible and quickly adapt to changing situations.
Strong conceptual/analytical quantitative skills
Knowledgeable with risk assessment tools and technics (e.g., FMEA)
Ability to work independently
MS office skills (e.g., Excel and Power Point), Think Cell (advantage)
Sr Director Global Engineering Center of Excellent, Global Engineering
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 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 laws.
EOE including disability/veteran