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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)Continued Process Verification (CPV) and AMB (Annual Monitoring Batch), data trending and statistical analysis Collect and review the technical content and scientific rational of CPV/AMB related documentation provided by the CMO (protocols/report, risk analysis).Eventually contributes to the writing of CPV/AMB related documentation Track CPV/AMB parameters provided by the CMOs. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trendingCollect and consolidate in CPV/AMB related KPI (i.e. dashboard, database) Investigations/DeviationsCollect, consolidate and review data to support investigations/deviation processes Ensure follow-up of CAPA plansValidation Collect and review and the technical content and scientific rational of Validation related documentation provided by the CMO (protocols/report, Quality Risk Assessment, validation master plan)Eventually contributes to the writing of Validation related documentation Supports Validation Lead and Experts in the implementation and the tracking of Global Validation Program (GVP) and related Validation Plan and Scheduling (VPS) executionCollect and consolidate relevant data for Validation KPI using ad hoc established reporting tools (i.e. dashboard, database) Contribute to the maintenance of the Validation Inventory (i.e. numbers of products, and accuracy of the information)Change control Contributes to the Change Control process through evaluation and execution phase (i.e. validation assessment, Product Quality Risk Assessment) by providing technical relevant information and scientific rational (i.e. validation strategy, technical memorandum)Annual Product Review/Product Quality Review (APR/PQR) Contribute to APR/PRQ related activities (e.g. regulatory check, product/process performance review, validation status) with collecting, reviewing and analysing relevant data and providing ad hoc summary.Training Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.Audit support Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.Data management Execute specific tasks to support data management (e.g. specifications management, artwork repository management, arranging documentation for regulatory submission)Ensure that product related data and information are maintained and kept up to date in related database (e.g. SharePoint)Minimum requirementsRelevant Experience 5 to 10 years experience in Manufacturing/ Manufacturing Science and Technology/Technical Development/Quality in Pharnaceutical Industry.Thorough understanding of manufacturing processes and related process equipment. Strong working knowledge of quality systems and Pharma regulatory requirements across multiple health authorities.Experience in executing process and cleaning validation. Experience in executing packaging equipment qualification (primary/secondary on semi-automated/automated equipment)Experience with validation of packaging processes (blistering, bottling, cartoning and hand packaging) of solid oral dosage forms, liquids and suppositories. This includes knowledge of various packaging material types (raw materials), IPC and release test methods for package integrity Expert in reviewing and writing technical reports.Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Fundamental understanding of standard pharmaceutical analytical testing.Fundamental understanding in SPC (Statistical Process Control). Sound experience of data handling and applied statistics is a must.
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


Clinical Research | Data Management/ Statistics
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