Job Posting: Quality Analyst III
Date Posted: September 3, 2024
Location: Gajraula, India, 244235
Company: Teva Pharmaceuticals
Job ID: 54656
Who We Are
At Teva Pharmaceuticals, we are committed to making good health more affordable and accessible for millions of people around the world. We are a global leader in the production of generic medicines, with a presence in nearly 60 countries. Our diverse team, representing a rich variety of nationalities and backgrounds, is united by a common mission to improve lives. Every day, at least 200 million people take one of our medicines—a testament to our impact. We are always looking for new ways to make a difference and welcome new talent to join us in this mission.
Role Overview: Quality Analyst III
As a Quality Analyst III, you will play a critical role in ensuring our site’s regulatory compliance, managing audits, and maintaining quality standards. You will be responsible for overseeing compliance activities, managing communications with regulatory agencies, and ensuring that our site remains inspection-ready at all times.
Key Responsibilities
Regulatory Compliance and Audits
- Regulatory Audits: Manage regulatory authority and external compliance audits (e.g., customer audits) including communication, tracking, and resolution of observations.
- Communication with Regulatory Agencies: Handle all communications with regulatory agencies, including reporting and resolving any required actions.
- Compliance Assessment: Assess the regulatory compliance status of the site and implement CAPA (Corrective and Preventive Actions) to ensure ongoing compliance. This includes reviewing major/critical observations from other Teva sites and implementing CAPA as needed.
Internal Compliance Management
- Internal Audits: Conduct internal compliance audits, including communication, tracking, and resolution of observations.
- Quality and Compliance Review: Review regulatory and quality compliance requirements, inspection outcomes, and Global Notifications to Management. Perform gap assessments and monitor corrective action plans where necessary.
Site Licensing and Quality Management
- Site Licensing: Maintain and establish appropriate licensing with regulatory bodies where products are marketed.
- Quality Council Meetings: Execute site Quality Council meetings, including preparation, presentation, and tracking of resultant actions.
- Quality Technical Agreements (QTA): Establish/review QTAs with suppliers, subcontractors, service providers, and customers (TAPI as a supplier).
Supplier and Material Oversight
- Supplier Oversight: Oversee and review suppliers and materials used in production and processes.
Documentation and Record Management
- Site Master File (SMF): Draft, approve, and maintain the Site Master File.
- Documentation Processing: Manage the processing of documents through the generation, modification, review, and approval workflow, including SOPs, production records, test methods, protocols, reports, and labeling. Ensure proper archival of records.
Additional Responsibilities
- Handle additional responsibilities as assigned by the Manager – QA/Site Quality Head.
Experience and Qualifications
- Educational Background: MSC (Chemistry) or M Pharm.
- Professional Experience: 8+ years of experience in Quality Assurance.
Reporting Structure
- Reports To: Senior Manager, Quality Assurance
Teva’s Commitment to Diversity and Inclusion
Teva Pharmaceuticals is dedicated to creating an inclusive workplace that reflects the diverse world we serve. We are an equal opportunity employer, committed to providing equal employment opportunities 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 protected status. If you require accommodations during the recruitment process, please let us know. We are committed to supporting you and ensuring a confidential and accessible candidate experience.
Apply now to be a part of our mission to improve health worldwide.