Validation Specialist CSV
QLS are recruiting for a Validation Specialist CSV to join an important project with a Global Pharmaceutical Company at their site based in Bern on a contract basis until end of 2022 with option of an extension.
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 andreports
- Support test execution
- Support and train team members in CSV methodology
- Supporting the timely and effective completion of investigations, change controls and CAPA’s
Candidate’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, 21CFR 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 agreedtimelines.
- Good verbal and written skills in English, German is a plus
F or more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence inEnglish. Please quote reference QLS 00052156 in all correspondence.
