Summary

The purpose of the Investigation & Deviation Owner role is to work collaboratively with process experts and the multifunctional operations teams in Steriles/large molecules platform and take ownership of the deviation management for the site. The individual shall actively participate in investigations of Deviations/Complaints/OOXs by interacting with Cross Functional Teams (CFT) and implementation of Corrective and Preventive Actions (CAPA), Effectiveness Check (EC), Risk assessment and Quality management. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. The individual shall contribute to the enhancement of quality, productivity, and efficiency by supporting and driving improvements within the organization.

• The individual shall have a comprehensive understanding and experience of using Quality Risk management framework and shall possess excellent investigational report writing skills.
• The individual shall have hands-on experience of using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations.
• Experience in handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment
• Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support.
• The individual shall have broad experience working in GxP environment and handling procedural requirements for HA audits.
• The individual will also be responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE).
• Prior experience of handling internal and health authority audits and inspections is preferred
• Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable).
• Certification in investigation handling - Root cause analysis (RCA) is preferred.

• Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
• Min 5 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility
• Minimum of 5 years of pharmaceutical process validation and cleaning validation.
• Should be familiar and able to perform basic statistical evaluations using Minitab or other statistical analysis tools.
• Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
• Knowledge of risk assessment and risk management programs.
• Should be familiar with regulatory guidance on validation, product filing and post approval changes.
• Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.).
• Good communication, presentation and interpersonal skills.

• Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.