摘要
About the Role
- Advanced knowledge of latest instrumentation/equipment used in Analytical R&D including but not limited to chromatography (LC, GC), spectrometry (LC-MS, GC-MS), titrations and hyphenated techniques. Technical expertise in all the above-mentioned technologies and sound awareness of other technologies like thermal analyses, X-ray, etc.
- Sound understanding of CFR compliance Stakeholder management: Job role requires global interaction, so a good command over spoken and written English is a must. Budgeting: Capex & Opex QMS: Responsible for QMS activities related to calibration, instrument Re-qualification & retirement Team Leadership & Performance
- Lead and develop technical operations for consistent, high-level performance
- Conduct team performance reviews and set individual development goals
- Create a results-driven work environment aligned with organizational values
- Inventory & Asset Management
- Monitor and manage spares inventory and ensure accurate usage documentation Track monthly spares consumption and support procurement forecasting
- Oversee material movement processes to ensure traceability and compliance
- Equipment Management & Compliance
- Ensure continuous readiness and calibration of all analytical instruments
- Plan and execute Preventive Maintenance (PM) schedules and ensure adherence
- Maintain ALCOA+ principles across all service-related documentation and data handling
- Attend and resolve breakdown calls efficiently, minimizing downtime
- Provide hands-on support to end users for optimal equipment utilization
- Coordinate with vendors for timely service delivery, installations, and maintenance
- Vendor development and management. Evaluate vendor performance based on SLAs and recommend improvement initiatives. Support procurement processes through proactive demand planning and vendor engagement Reporting & Analytics
- Generate monthly reports covering breakdowns, calibrations, service logs, and utilization data
- Provide insight-driven dashboards and summaries for senior management
- Deviations & Change Control
- Manage and investigate equipment-related deviations in accordance with SOPs
- Initiate and track change control requests linked to instrumentation, processes, and materials
- Collaborate with QA and Regulatory teams for corrective and preventive actions (CAPA)
- Participate in audits, validations, and continuous improvement initiatives. Identify and implement process enhancements to boost service efficiency and compliance
Role Requirement
Education:
Engineering degree or equivalent 1).
1) Demonstrated, extensive experience and recognized expertise in the GxP area can override the training requirements.
Experience/Professional requirement:
• Recognized expertise in analytical. Relevant experience of working in a scientific and strategic environment.
• Thorough understanding of drug development processes.
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
• Demonstrated advanced coaching and mentoring skills.
• Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable.
• Excellent communication/presentation skills and scientific/ technical writing skills. Advanced coaching and mentoring skills.
Key Responsibilities, Accountabilities and Tasks
As per FRM-7011599 current version
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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