Job Opportunities in Turkey
August 30, 2024
Sandoz
Gebze
OTHER
Product Steward
Major accountabilities:
Cost, C-Sat and productivity targets -Achievement of project plans & milestones -Internal customer satisfaction with quality of services provided -Validation Master Plan (VMP) completed and up to date.
Work Experience:
- Technical Transfer Lead -Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
- Review first APQR after transfer to ensure adequate product performance -Ensure that all relevant technical information and documentation for validation is available.
- Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times).
- Coordinate technical, regulatory and validation batches at site.
- Support Validation Lead / Validation Expert in creation of validation protocol and report.
- Product Steward And -Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
- Create and maintain a product specific Quality Risk Analysis (QRAs).
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Review APQR and decide on state of control.
- Technical Steward -Act as the SPOC for the interface with global MSAnd T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
- Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (Do E).
- Provide technical expertise for validation activities around technologies within area of responsibility.
- Harmonize and optimize technical processes across the site.
- Validation Lead -Support Product Steward in maintaining the process control strategy.
- Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
- Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
- Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
- Senior Scientist MSAnd T -Complex projects with deep understanding of development process requirements -Difficult to solve topics (eg.
- new by-product investigation, complex deviations) -Cross product alignment in support approach (larger sites) -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Cost, C-Sat and productivity targets -Achievement of project plans & milestones -Internal customer satisfaction with quality of services provided -Validation Master Plan (VMP) completed and up to date.
Work Experience:
- Fix-its/Turnarounds.
- Operations Management and Execution.
- Collaborating across boundaries.
- Project Management.
- Applied Statistics.
- Assembly Language.
- Change Control.
- Chemical Engineering.
- Continual Improvement Process.
- Cost Reduction.
- Data Analytics.
- Electronic Components.
- General Hse Knowledge .
- Including Gdp.
- Knowledge Of Capa.
- Knowledge Of Gmp.
- Lean Manufacturing.
- Manufacturing (Production).
- Manufacturing Process.
- Manufacturing Technologies.
- Process And Cleaning Validation.
- Process Control.
- Process Simulation.
- Risk Management.
- Root Cause Analysis (Rca).
- Scientific Method.
- Six Sigma.
- Statistical Analysis.
- Technology Transfer.
- English.
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