Validation Specialist CSV

Zoek Pin Bernards Heath, Hertfordshire, England


Contract (Full time)

Posted 23 days ago

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 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

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, 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

For more information or to apply for this position, please contact Adrien on######### or email ######. Please could you send any correspondence in English. Please quote reference QLS 00052156 in all correspondence.

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