Validation Expert Role
About the Job
We are seeking an experienced Validation Expert to join our team. As a key member of our validation team, you will be responsible for ensuring that all equipment and systems meet the required standards for commissioning, qualification, and validation.
Key Responsibilities
* Equipment Installation and Validation Protocols: Coordinate the installation of equipment and develop draft validation protocols (IQ, OQ, PQ) in accordance with cGMP standards.
* Execution and Documentation: Execute and document IQ/OQ/PQ activities, ensuring compliance with cGMP requirements.
* Validation Documentation: Develop and manage validation documentation, including URS, DQ, FMEA, risk assessments, FAT, and SAT.
* Cycle Facilities and Systems: Conduct and document validation for facilities, systems, and utilities throughout the validation life cycle.
* Risk Assessments and Gap Analysis: Perform GAP analyses and risk assessments, applying lessons learned to improve validation processes.
* Quality Systems Activities: Execute Quality Systems activities, including document management, change control, non-conformities, and CAPA.
Requirements
* Education: Bachelor's degree in a scientific or technical discipline.
* Experience: 5-10 years of experience in the pharmaceutical industry at an advanced level.
* Language Skills: Fluency in both German and English (written and spoken).
Skills and Qualifications
* Technical Writing: Strong technical writing ability for accurate and timely documentation.
* Communication: Effective written and verbal communication across departments.
* Organizational Skills: Proficient in organizing and managing time across multiple tasks.
Ongoing Development
This role requires a commitment to ongoing learning and professional development, as well as a willingness to adapt to changing priorities and requirements.