Beschreibung
A Pharmaceutical company is searching for:Validation Engineer (CSV)
Main Responsibilities
? Coordination of computerized system qualification and validation activities within the Quality Control department
? Define the validation strategy
? Perform and/or support the writing of specification documents (URS)
? Review test protocols, plans and reports
? Support test execution
? Support and train team members in CSV methodology
? Supporting the timely and effective completion of investigations, change controls and CAPA's
Requirements:
? Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
? Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
? Good understanding of analytical technologies,
? Strong analytical thinking and problem-solving ability
? Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
? Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
? Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
? Good verbal and written skills in English, German is a plus
Michael Bailey International is acting as an Employment Business in relation to this vacancy.