
Expert Science
5 days ago
Major accountabilities:
- Plan, organize, execute, and document scientific experiments (e.g., analytical
method developments/ validations/ transfers/ stability/ release testing, formulation
development analytics etc.) according to the agreed timelines and appropriate
quality standards. - Accountable for documentation and submission of raw data in appropriate data
system (for e.g., LIMS test activation and results entry). - Responsible for good documentation practices (GDP) and good laboratory
practices (GLP) during execution of laboratory activities. - Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
- Responsible for assigned laboratory related area/activities (e.g.,
chemical/reagents/consumables/samples/column/ glassware management etc.). - Responsible for implementation and maintenance of lean/efficient/environmentally
sustainable practices in the laboratory. - Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
- Responsible to meet KQI (Key quality indicators) and KPI (Key performance
indicators) for all assigned activities. - Support internal and external audits and ensure no critical findings within the
assigned scope. - Actively contribute to team and organization goals.
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis
Guidelines. - Additional specific roles/tasks: See Up4Growth training assignments for the
business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth).
Minimum Requirements:
- Technician or Bachelors/Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent.
- Fluent in English (oral and written).Knowledge of site language, if required.
- Knowledge in quality principles driving drug development such as GMP.
- Understanding of general regulatory and quality expectations.
- Good scientific background, communication skills including presentation and scientific/technical writing.
Work Experience:
- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills:
- Environment.
- Experiments Design.
- Health And Safety (EHS).
- Laboratory Equipment.
- Manufacturing Process.
- Materials Science.
- Process Simulation.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.
Languages :
- English.
-
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