Job 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 environment. 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 efficient 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

• 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 efficient workflow, procedures, policies, and validation inspection programs are implemented and maintained across manufacturing operations

• Manage in-process product quality and validation outcomes in coordination with vendors and contract manufacturers

• Communicate with customers and vendors to investigate and resolve quality and validation-related issues in a timely manner

• Report and troubleshoot manufacturing process deviations and defects identified during validation studies and finished goods inspection

• Support the development and maintenance of validation master plans, protocols, and reports in accordance with regulatory requirements

• Identify and implement process improvements to reduce costs, defects, errors, and rework in validation and manufacturing operations

Additional Responsibilities: Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses: