Validation Specialist

Job Title: A Pharmaceutical Validation Expert About the Role: Support various aspects of validation including sterilization, cleaning, isolator operations and filter validation. Develop qualification/validation documentation and cycle development studies in line with the standard approval process. Resolve technical issues encountered during study execution and provide technical input into quality notifications. Perform root cause analysis of system failures and support continuous improvement through Lean Six Sigma methodologies. Drive compliance of regulatory requirements and execute current Good Manufacturing Practices (cGMP) in day-to-day activities. Requirements: Considerable experience in a comparable role in a GMP manufacturing setting. Relevant technical qualifications in pharmaceutical sciences or technical engineering. Knowledge of CTU equipment qualification and thermal mapping skills. Exception/Deviation Management and Change Control, leadership skills, and project management skills. Proficiency in Microsoft Office and excellent communication, presentation, and interpersonal skills. Education: Relevant technical qualification(s) in pharmaceutical sciences or technical engineering.

Creado: Jue, 01 de Ene de 1970