Senior Technology Professional

Job description

Technical Lead on pharmaceutical processes, equipment/computer systems specifications, operations, troubleshooting, qualification and validation, instrumentation, process control, Process Analytical Technology (PAT), software programming/configuration and related technical support. Coordinates and conducts Computer System Validation and qualification to required systems and equipment. Develops and maintains administration and support model for process controls systems following applicable procedures. Provides and coordinates technical support for manufacturing, bulk packaging and lab equipment/systems. Assures that all assigned projects are conducted in compliance and following IPR/AZ procedures and guidelines. Provides leadership and advance professional technical guidance in field of expertise to the organization. Typical Accountabilities: Defines and manages validation strategy for Computer Systems/Equipment, considering operational and regulatory requirements. Writes Computer System Validation and equipment qualification required documents as per applicable procedures. Defines/writes User & Functional Specifications and Risk Assessment documents. Supports audit process, as requ...