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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
The incumbent shall liaise with stakeholders in Sandoz Development Centre PD project team for Root Cause Analysis, conduct review and facilitate on time closure of Non - conformances, Change requests, CAPA, provide Supplier related metrics and assist in preparation of documentation. Your responsibilities: 1. Provide assistance to the Project and Line function teams on the quality standards and compliance for the project assigned to the individual. 2. Is on the ground for the production of non - commercial batches (e. g. technical batches and registration/ validation batches) and provides inputs to Dev QA Manager/ Senior Specialist to facilitate the decision making for disposition of batches. 3. Write the respective quality documents of the projects, e. g. Master Batch Records, executed batch records, other manufacturing documents, Process Validation documentation, Method Validation Protocols/ Plans and Reports, Stability documentation, study protocols and reports regardless if these documents are internally and externally created. To do so requests associated data such as analytical test results, water testing data, environmental monitoring data (as applicable) regardless of the format of the data (charts, forms, print - outs) . 4. Shall liaise with the stakeholders for Root Cause Analysis, conduct review and facilitate on time closure of Non - conformances, Change requests, CAPA. 5. Immediately escalates quality and compliance issues to SDC Quality Management and / or to respective team leads / function heads as applicable. 6. Provide the data required for Metrics, QSR etc. 7. Shall support Dev. QA manager in preparation of supplier Qualification documentation like updating the ASL, questionnaires for supplier qualification, QAA etc. 8. Tracking of trainings. 9. Any other task as assigned by the management. Minimum requirementsWhat you ll bring to the role: Minimum Bachelor Degree in science or relevant discipline Desired Masters in Science or relevant discipline Proficiency in English. Knowledge about any other language is an advantage. 1. Minimum of 1 - 3 years of relevant industry experience 2. 1 year of QA experience 3. Adequate/ fundamental knowledge of Quality management, GxP, regulatory guidelines 4. Ability to analyze and evaluate GxP compliance 5. Good operational excellence skills 6. Ability to look into details 7. Basic knowledge of Drug Development ProcessWhy consider SandozOur number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA - cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever - more digital and global worldThe answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. Join us, and help reimagine access to medicine. DivisionSANDOZ Business UnitProduct Dev SZ CountryIndia Work LocationHyderabad, AP Company/ Legal EntityNov Hltcr Shared Services IndFunctional AreaQuality Job TypeFull TimeEmployment TypeRegular,
Keyskills :
testcasesregressiontestingautomationrootcauseanalysissharedservicesdrugdevelopmentqualityunctionalrequirementscontinuousimprovementfacilitationrootcausewatertestingbatchrecchangerequests