Job Description Summary
The purpose of the Investigation & Deviation Owner role is to work collaboratively with process experts and the multifunctional operations teams in large molecules platform (Biologics site) 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.
Job Description
Major accountabilities:
Lead and support complex investigations and deviation management activities related to manufacturing processes, products, and equipment within biologics manufacturing.
Apply structured Root Cause Analysis (RCA)
methodologies, including 5 Whys, Fishbone Diagrams, impact assessments, timeline analysis, and process mapping to identify and resolve issues.
Conduct quality risk assessments and utilize Quality Risk Management (QRM) frameworks to support robust decision-making and compliance.
Author and review high-quality investigation reports, ensuring accurate documentation, scientific rationale, and effective CAPA implementation.
Provide technical and scientific expertise on process-related issues, supporting continuous improvement and operational excellence.
Ensure compliance with cGMP requirements, SOPs, health, safety and environmental standards, and other applicable regulatory and quality guidelines.
Support validation, manufacturing operations, and process monitoring activities, including sampling, routine monitoring, and ongoing process support.
Drive inspection readiness and support internal audi