Development QA Specialist

Job Description

The incumbent will be the lead development QA representative in the SDC (Sandoz Development Centre) PD project team. Provide guidance, quality compliance support, performs document approval, support the supplier evaluation, establish Quality Agreements and will be a part of the due diligence team, act as quality representative (if required) in the plant for the production of non - commercial batches, supports the dossier review and respective product launches. 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. Participate in due diligence visits/ audits at suppliers/ CMOs/ CROs and assist Dev QA Manager for evaluation of the supplier from Quality standpoint. 3. 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 to facilitate the decision making for disposition of batches. 4. Independently reviews 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 created internally/ externally. 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) . 5. Reviews independently OOSs, Deviations, CAPAs, change Controls in relation to the development projects. Verifies that all excursions from written procedures have been documented and explained according to the respective quality incident reporting procedure (s) . In addition to this, the individual shall assist in investigation as and when required. 6. Supports for the preparation of product launch - support of Pre - Approval Inspection (PAI) and definition of CMO preparation programs for PAI. 7. Supports the execution of audit plans for both internal and external audits. 8. Immediately escalates quality and compliance issues to SDC Quality Management and / or to respective team leads / function heads as applicable. 9. Facilitate Supplier CAPA closure 10. Approves Test Methods. 11. Tracking of trainings. 12. 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 4 - 6 years of relevant industry experience. 2. A minimum of 2 - 3 years of Dev QA experience 3. Detailed knowledge of Quality management, GxP, regulatory guidelines 4. Proven ability to analyze and evaluate GxP compliance 5. Good organizational and decision making skills 6. Communication skills to sufficiently address GxP and logistic related questions with the line unit and the project management team 7. Basic knowledge of Drug Development process. 8. Detail orientationWhy 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 :
testcasestestscenariostestcasedesigntestexecutionenvironmentduediligenceproductlaunchsharedservicesdrugdevelopmentontinuousimprovementfacilitationwatertestingbatchrecleaddevelopment