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Quality Analyst Iii

8+ years
Not Disclosed
10 July 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Us

We are dedicated to making good health more affordable and accessible, aiming to improve the lives of millions worldwide. Our mission connects us across nearly 60 countries, bringing together a diverse range of nationalities and backgrounds. As a leading manufacturer of generic medicines and a proud contributor to the World Health Organization’s Essential Medicines List, we reach at least 200 million people daily with our products. We are continually seeking new ways to make a difference and new people to help us in this endeavor.

Role Overview

Position: Compliance and Quality Assurance Manager

Location: [Specify Location]

Reports To: Senior Manager Quality Assurance

Key Responsibilities

  • Regulatory Audits Management: Oversee and manage regulatory authority and external compliance audits, including customer audits. Handle communication, track observations, and ensure resolution of any issues.

  • Regulatory Compliance: Assess and maintain the site’s regulatory compliance status. Implement CAPAs based on major/critical observations from other Teva sites to ensure constant inspection readiness.

  • Internal Compliance Audits: Perform and manage internal compliance audits, including communication, tracking, and resolution of observations.

  • Regulatory Requirements Review: Review regulatory and quality compliance requirements, inspection outcomes, global notifications to management, and perform gap assessments. Monitor and manage corrective action plans as necessary.

  • Licensing and Quality Council: Ensure appropriate site licensing with regulatory bodies and execute Quality Council meetings, including preparation, presentation, and tracking of actions.

  • Supplier and QTA Management: Establish and review Quality Technical Agreements (QTAs) with suppliers, subcontractors, service providers, and customers. Oversee supplier and material quality for production and processes.

  • Site Master File (SMF): Draft, approve, and maintain the Site Master File (SMF).

  • Documentation Management: Oversee the generation, modification, review, and approval of documents, including SOPs, production records, test methods, protocols, reports, and labeling. Ensure proper archival of records.

  • Additional Responsibilities: Undertake other tasks as assigned by the Manager – QA / Site Quality Head.

Experience and Qualifications

  • Educational Background: MSC (Chemistry) or M Pharm.
  • Experience: Minimum of 8 years of relevant experience in quality assurance and regulatory compliance.
  • Skills: Strong understanding of regulatory compliance, audit management, CAPA implementation, and documentation processes.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to providing equal employment opportunities regardless of 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 protected by applicable laws. We promote a diverse and inclusive workplace for all. If you require any accommodations during the recruitment and selection process, please inform us, and we will ensure that your needs are met confidentially.