Delegeret Qualified Person

The role of Delegeret Qualified Person requires a comprehensive understanding of pharmaceutical quality assurance and regulatory compliance. Candidates should possess in-depth knowledge of Good Manufacturing Practices (GMP) and relevant pharmaceutical legislation to ensure the quality, safety, and efficacy of medicinal products. The position demands proficiency in overseeing batch release processes, quality control, and documentation management. Experience in risk assessment, deviation handling, and CAPA (Corrective and Preventive Actions) implementation is essential. Strong analytical skills and attention to detail are critical for evaluating production data and quality reports. Effective communication skills are necessary for liaising with regulatory authorities, production teams, and quality departments. The role typically requires formal education in pharmacy, chemistry, or a related scientific discipline, complemented by specialized training or certification as a Qualified Person. Familiarity with quality management systems (QMS), audit procedures, and validation processes is advantageous. Candidates should demonstrate the ability to work independently, make informed decisions, and maintain compliance with evolving regulatory standards. Overall, the Delegeret Qualified Person must combine scientific expertise, regulatory knowledge, and practical experience to uphold the integrity of pharmaceutical manufacturing and release operations.