Summary
About the Role
Major accountabilities:
- Provide analytical and technical support to project teams at various stages of product development (eg. CSF, FMI and LCM).
- Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.).
- Support Analytical project leader for setting analytical development strategy.
- Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.
- Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples).
- Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities.
- Provide requests for lab activities to the associates and stakeholders.
- Manage project activities including logistics at third parties and external testing laboratories.
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
- Single point of contact for PHAD/CHAD/ARD and other stakeholders for project execution activities.
- Support internal and external audits and ensure no critical findings within the assigned projects.
- Actively contribute to team goals.
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
Key performance indicators:
- Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
- Feedback from other team members/leaders.
- Refer to annual individual and team objective setting.
- Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
- Feedback from other team members/leaders.
- Refer to annual individual and team objective setting.
- Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
Minimum Requirements: Masters + 7 years or PhD + 2 years
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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