About the company
RAFARM is an innovation-driven, dynamically growing pharmaceutical company and a well-established European manufacturer with an outward-looking orientation that invests 13% of net turnover in Research and Development. We introduce high technology in our state-of-the-art sterile manufacturing plant and create new production lines with cutting-edge technology and robotic equipment. RAFARM is a place where our people evolve and are full of passion and interests. We are a dynamic team that empowers talent, embraces diversity and accelerates development.
About the role
Our Quality Assurance department is expanding, and we are in search of a diligent and meticulous Quality Assurance Validation/Qualification Officer This role will be pivotal in upholding quality standards, validating processes, and ensuring compliance with regulatory guidelines for the timely release of our pharmaceutical products.
The role main accountabilities will be the following:
· Implements the calibration plan and validation master plan for process equipment, utilities, cleanrooms and warehouses
· Prepares the validation reports, protocols and participates throughout these activities
· Identifies the deviations and participates in the investigations related to initial or requalification activities
· Revise Standard Operating Procedures related with qualification of process equipment, utilities, cleanrooms and warehouses
· Monitors the preventive qualification/calibration program in order to coordinate re-evaluations
· Liaises with the technical department regarding maintenance issues and investigates whether the equipment, system or facility is affected
Requirements
Experience & Qualification Standards:
· University or technical degree in engineering or relevant scientific discipline
· Minimum of 1 year of relevant experience in a Quality Assurance or Technical department at a pharmaceutical manufacturing industry
· Highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude
· Fluent in English and MS office proficient
· Self-motivated, flexible, and adaptable
Benefits
