Job Description
Job Purpose
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 Accountabilities
For 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 knowledge:
Support 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 trending
Collect and consolidate in CPV/AMB related KPI (i.e. dashboard, database)
Investigations/Deviations:
Collect, consolidate and review data to support investigations/deviation processes
Ensure follow-up of CAPA plans
Validation:
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) execution
Collect 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)
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 Accountabilities
For 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 knowledge:
Support 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 trending
Collect and consolidate in CPV/AMB related KPI (i.e. dashboard, database)
Investigations/Deviations:
Collect, consolidate and review data to support investigations/deviation processes
Ensure follow-up of CAPA plans
Validation:
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) execution
Collect 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)
Company Profile
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Posts
