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.
Key Responsibilities:
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.
Essential Requirements:
Bachelors 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.
Desirable Requirements:
Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
