Quality Control Qualification and Validation Specialist
Posted on Mar 12, 2021 by Michael Bailey Associates - UK Contracts
Working for Medical Device client in Switzerland.
Job Title: Quality Control Qualification and Validation Specialist
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
Experince & Qualifications
Degree in a LifeSciences/Biotechnology, Chemistry discipline or comparable work experience
Qualification & Validation of lab equipment in a Pharmaceutical envionment 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
Excellent communication and teamwork skills
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.