Job Description

Who are we?

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!



Main Responsibilities: * Maintaining a quality assurance system and GMP in according with up-to-date requirement of the regulatory authorities.

• Responsibility for a quality assurance system that is applicable to:
• The company\'s employees.
• Production processes.
• Product development activities
• Logistic processes affecting product quality.
• Releasing or rejecting all APIs, Releasing or rejecting intermediates for use outside the control of manufacturing company.
• Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
• Making sure that critical deviations and OOS results are investigated and closed and implementation and verification of CAPA closure.
• Review, approval and maintaining of the documents related to monographs, Validation master plan, site master file, Laboratory information file, SOP\'s, equipment qualification, general system validation, batch cards, process validation and cleaning validation.
• Basic GMP, Refreshing/updating GMP training / data integrity training to all company employees.
• Approving intermediate and API contract manufacturer as applicable.
• Approving all changes that potentially affect intermediate or API quality.
• Review and verification of documents and updation in computerized system.

Short Description

11. Maintaining a set of procedures that support the quality assurance system.

12. Maintaining a set of specifications for all the company materials/products.

13.Making sure that effective systems are used for maintaining and calibrating critical equipments.

14. Handling of customer and regulatory inspections.

15. Handling of customer queries and complaints.

16. Carrying out quality system audits / internal audits to verify compliance with principles of GMP.

Long Description

17. Performing product quality reviews.

18. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and /or intermediates where appropriate.

19. Performing vendor / service provider audits as and when required.

20. Performing risk assessment for all APIs being manufactured at site.

21. Approving the vendors.

22. Responsible for assisting Head of Quality Function TAPI India and approving related documents as a proxy to Head of Quality Function TAPI India.

23. Any other responsibilities assigned by Site Quality Head TAPI India.

Qualifications

B.Sc/M.SC/ Engg in Chemistry or Chemical

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

Sr Director, Site Quality Head, Quality Assurance

Competencies

AC - Analytical Thinking

AC - Communicating & Influencing

Values -Getting It Done Together

Motivation & Career Trajectory

Manager Principles -Drive Execution with Discipline & Diligence

5. Functional - Key functional requirements set by hiring manager

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:

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.

Teva Pharmaceuticals