The opportunity
The main purpose of this role is to implement the strategy and to determine the methodology of for the validation of the production processes.
How you’ll spend your day
• Create the process validation strategies in accordance with the requirements of the company's policy for validation and maintenance of the validation status
• Participate in validation activities, by implementing harmonized corporate methods and validation documents, in order to achieve compliance with all GMP requirements of the regulatory agencies for which Dupnitsa is approved and certified for the export of medicinal products
• Execute tasks based on the corporate policies and on the basic and the standard operating procedures for validation
• Prepare or participate in the preparation and verification of the SOPs and the formats related to process validation activities
• Create the monitoring strategies
• Prepare risk assessment to determine the number of batches needed for the process validation
• Perform statistical analysis to assess the sustainability of the processes
• Participate in planned and unplanned inspections and customer audits
• Work on the material change
• Participate in activities related to Quality Improvement Programs (Product and Process Review) and other
