Quality Sr Specialist
Bangalore, India, 560064
Who we are
How you’ll spend your day
- Review and approval of method validation protocols and reports
- Review and approval of method transfer protocols and reports
- Review and approval of development study protocols and reports
- Review and approval of equipment/instrument calibration and maintenance records
- Review and approval of equipment/instrument validation/qualification documentation
- Review and approval of software validation/qualification documentation
- Review and approval of cleaning validation/verification documentation
- Review and approval of change controls related to SOPs, test methods, specification documents, forms, master batch records, and master packaging records
- Review and approval of test methods, specification documents, SOPs, master batch records, and master packaging records
- Review and approval of executed batch records and executed packaging records
- Review and approval of laboratory test data for raw materials, components, intermediates, and finished products
- Review and approval of stability data and stability summary reports
- Review and approval of environmental monitoring data/reports and associated documentation
- QA release of raw materials, components, and finished product batches
- Creation of new or revision of existing SOPs
- Support regulatory, external, and Teva global audits
- Support the Inspection Readiness Program
- Complete training assignments timely by the due date
- Assist with document number issuance for controlled documents
- Attend assigned meetings and provide updates as needed
- Assist with compiling site metrics, KPIs, and trend reporting
- Review of environmental monitoring charts and associated documentation
- Conduct corporate standards gap assessments
- Support the Vendor Approval Program (review of vendor documentation, QTAs, etc.)
- Train and maintain proficiency with computerized systems (Glorya, Veeva, Studium, IT systems, etc.)
- Perform other activities as assigned by the manager
Your experience and qualifications
- Required undergraduate BA/BS degree in Life Sciences or related field
- A minimum of 3-5 Yrs of experience in Pharmaceutical QA GMP environment
- Equivalent combination of education and/or relevant work experience will be considered
Already Working @TEVA?
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Teva’s Equal Employment Opportunity Commitment