Description
Description:
This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products within a global pharmaceutical setting. The position builds and maintains the infrastructure and systems necessary to consistently ensure the timely delivery of quality-compliant products. It supports the auditing, monitoring, and evaluation of validation activities against defined internal and regulatory standards. The role ensures productive and effective workflows, procedures, policies, and validation programs are in place and adhered to across manufacturing operations. It manages in-process product quality in coordination with vendors and contract manufacturers. The position facilitates communication with customers and vendors to resolve quality-related issues in a timely and compliant manner. It reports and troubleshoots manufacturing process deviations and defects identified in finished goods and validation studies.
The role contributes to continuous improvement initiatives aimed at reducing defects, errors, and rework across manufacturing operations. It also supports the development and maintenance of validation master plans and related documentation.
Essential Functions:
Define and specify quality activities, processes, and standards for validation programs in compliance with regulatory requirements
Lead risk-based validation strategies using quality risk management principles to optimize validation efforts
Build and maintain quality infrastructure and systems to ensure timely delivery of validated and compliant pharmaceutical products
Conduct audits and monitoring of validation activities and manufacturing processes against internal and regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines
Ensure productive workflow, procedures, policies, and validation inspection programs are implemented and maintained across manufac