Experience Inc. Jobs

Quality Analyst III

Date: Sep 3, 2024

Location:

Gajraula, India, 244235

Company: Teva Pharmaceuticals

Job Id: 54656

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• Responsible for Management of Regulatory authority and other external compliance audits (e.g. customer audits) including communication, tracking and resolution of observations. Management of communications with Regulatory agencies including required reporting and resolution of any actions required by the agencies.

• Responsible for Assessment of the Regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes review of major/critical observations from other Teva sites and implementation of CAPA as appropriate. Requirement for sites to remain inspection ready at all times.

• Responsible for Performance, reporting, and execution / management of internal compliance audits including communication, tracking and resolution of observations.

• Responsible for Review of regulatory and quality compliance requirements, inspection outcomes, Global Notifications to Management, and performance of gap assessments covering all areas of applicability. Monitoring of corrective action plans where needed.

• Maintaining as well as responsible for establishment of appropriate licensing of a site with the regulatory bodies where products are marketed.

• Responsible for execution of the site Quality council meetings including preparation, presentation, and tracking of resultant actions.

• Responsible for Establishment/review of QTA’s with suppliers/subcontractors/service providers required for the site. Establishment/review of QTA with customers (TAPI as supplier).

• Responsible for Oversight and review of suppliers and materials for use in production and processes.

• Responsible for Drafting, approval and maintenance of a Site Master File (SMF).

• Ensuring Quality interface with internal and external customers when dealing with activities such as QTAs, supplier qualification, issue resolution, product information, or for movement of materials, products, or process from site to site.

• Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records.

• Additional responsibilities assigned by the Manager – QA /Site Quality Head.

Your experience and qualifications

• MSC (Chemistry)/ M Pharm with 8+ years of experience.

Reports To

Senior Manager Quality Assurance

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran