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Technical Specialist ESO MS&T

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

The Technical Specialist supports the ESO Technical Managers by collecting data, reviewing or writing technical documents related to validation (e.g. process validation, CPV/AMB, cleaning validation, packaging), APR PQR, technical files, product risk assessment.The scope includes all drug products bulk (DP), finished products (FP) and all chemical intermediates/APIs under ESO responsibility. For that purpose, He/She collects data from the CMO (Contract Manufacturing Operation) or Novartis Business Units.For a limited number of products He/She also contributes to the product stewardship with supporting ESO Technical Manager in product oversight throughout the lifecycle. Major AccountabilitiesFor the major accountabilities listed below the Technical Service Specialist -Collects and analyses data (i.e. validation, CPV/AMB, APR/PQR, product technical files, analytical and related testing monography) eventually including statistical analysis-Performs reviews against template for completeness of documentations -Provides input and review of such documents against standards and templates-Discuss and formalize (e.g. technical report) the outcome of the technical reviews (all data discussed and reviewed with ad hoc ESO Technical Manager) Process/product oversight and knowledgeSupport maintenance of the knowledge and the history of the product(s) process throughout the entire commercial lifecycle (i.e. maintenance of technical documentation such as Technical Files or product specific Quality Risk Analysis) Collect and review data to contribute or personally ensure Product Quality Risk Assessment (i.e. HLPA)
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 5-10


Product Development | Production Management | Production/Manufacturing/Maintenance
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