Role Overview:
The Senior Executive Validation is responsible for planning, executing, and reporting of Process validation, hold time study and equipment qualification to ensure timely completion of validation projects and regulatory compliance. The role ensures compliance with scientific, quality, and regulatory requirements while supporting data analysis, investigations, and continuous improvement initiatives.
Job Responsibilities:
Planning, execution, and documentation of Process Validation activities in compliance with current GMP guidelines and regulatory requirements.
Design and execution of Hold Time Studies for manufacturing processes, including sampling plans, evaluation of results, and preparation of validation reports.
Qualification of manufacturing and support equipment, including preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Development, review, and approva...