Quality Analyst II (TAPI) at Teva Pharmaceuticals, B.Sc/Msc in chemistry- Apply Now
Are you an experienced Quality professional with a B.Sc/M.Sc. in Chemistry and 4 to 10 years of experience in the pharmaceutical industry, particularly with Active Pharmaceutical Ingredients (APIs)? Teva Pharmaceuticals (TAPI division), a leading global supplier of APIs, is seeking a dedicated Quality Analyst II to join our team in Gwalior, India. If you have a strong understanding of GMP, validation processes, and regulatory compliance within the API sector, we encourage you to apply!
How do you spend your day as a Quality Analyst II
As a Quality Analyst II at Teva Pharmaceuticals (TAPI), your responsibilities will include:
- Collection, compilation, analysis, and review of all data for APQR.
- Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow.
- Review/approval of all documentation associated with the process validation, CPV & cleaning validation.
- Processing of documents through the generation, modification, review, approval and archival of records.
- Responsibility of Quality Analyst II for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
- Tracking, trending, and reporting of Quality Metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
- Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
- Quality Analyst II has to Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.
- Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations.
- Management, tracking, and/or performance of GMP-type training supporting plant performance and Quality Departmental training and hands-on qualification.
- Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and/or the utilities associated with the site.
Your experience and qualifications
- B.sc/Msc in chemistry
- 4 to 10 years of experience
Keywords: Quality Analyst, TAPI, Gwalior, India, Teva Pharmaceuticals, API, pharmaceutical ingredients, R&D, validation, compliance, regulatory affairs, GMP
