Qualification Validation Engineer
You will manage all equipment, systems process, and product related qualification and validation activities, except GXP related computerized systems for the Wuxi site, ensure continuous compliance status of the equipment and the processes.
The position is critical to the compliance effort and is responsible for assuring compliance of validated systems, process, and equipment to current cGMP, FDA, EU, USDA and Corporate requirements. The scope includes Manufacturing, Quality Control, Facilities and Utilities.
Main missions : Develop expertise and manage projects related to the manufacturing processes
– Maintain comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant equipment, systems and processes
– Responsible for implementing current trends in regulatory compliance for all validation procedures for equipment, systems and processes. Author, implement and update the validation master plan (VMP) to assure compliance with regulatory and corporate requirements
– Providing support to Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future DQ/IQ/OQ/PQs can be performed on equipment sourced
– Follow site/company procedures and cGMP to lead/execute validation or study activities related to the manufacturing processes, quality control, cleaning, utilities and facilities and provide associated validation files.
– Follow site/company procedures to lead/execute qualification activities related to equipment, systems and provide associated validation files
– Share experience with other sites of the company. Train employees to the qualification process. Train employees to the validation process. Present processes and qualification/validation files during audits
Required skills :
– Education : Diploma in chemistry and/or chemical engineering (chemical process)
– Ability to manage data and statistical analysis
– Ability to manage projects
– Min 5 years working experiences in pharmaceutical/chemical industries, Strong GMP mindset
– Pay attention to details, Ability to work in a fast paced environment communicate, Ability to work in a multi-cultural environment, Good team player
– Language : English in day-to-day management and interfacing, local language is a plus