Job Description Summary
Plays a pivotal role in leading the instrumentation services team and managing analytical instruments across the facility. This role is responsible for ensuring operational efficiency, quality compliance, accurate reporting, and continuous improvement in line with pharmaceutical industry standards. Lead, manage & optimize all technical operations related activities, contribute to overall ARD strategies and goals. Data mining & implement best practices across industry. This role requires a strategic approach to reduce costs, increase speed of delivery, and improve overall customer satisfaction.
Job Description
- 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
Skills Desired
Analysis, Databases, Decision Making Skills, Operations, Problem Solving Skills, Reporting, Team Management, Waterfall Model