Aufgaben

  • Ensure qualification/validation plans are in place for equipment, infrastructure, and computerized systems
  • Oversee the execution of qualification and validation protocols, ensuring compliance with Quality standards
  • Approve SOPs, protocols, and reports for commissioning, qualification, and validation activities
  • Act as a quality assurance leader, overseeing qualification and validation efforts throughout all design phases of large CAPEX projects (e.g., new drug product facilities)
  • Provide QA leadership and oversight for ongoing qualification/validation activities on aseptic fill-finish processes, including filling equipment, lyophilization, clean utilities, and clean room facilities
  • Ensure selected vendors are qualified and compliant with project requirements and Quality standards
  • Manage and ensure compliance with relevant global systems (e.g., Kneat, Trackwise, DMS, Unifier) for documenting qualification/validation activities and deviations
  • Oversee the preparation and approval of key documentation such as URS, FAT/SAT, CQV/CSV documents, and other project-related documentation

Qualifikationen

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
  • Significant experience working in the GMP-regulated pharmaceutical industry, particularly in Quality Assurance or related roles
  • Expertise in Computer System Validation (CSV) and Automation within the GMP context, especially for aseptic fill-finish processes, equipment, and utilities
  • Hands-on experience with qualification and validation of systems related to aseptic facilities (e.g., filling equipment, lyophilization, clean utilities, and clean room facilities)
  • Proven track record in overseeing large CAPEX projects and managing qualification/validation processes from design to execution
  • Strong understanding of GMP regulations and industry standards related to equipment and system qualification
  • Proficient in the use of global qualification/documentation management systems such as Kneat, Trackwise, DMS, and Unifier