Validation (Quality Control Qualification and Validation)
Quality Control Qualification and Validation Specialist
Experis is the global leader in professional resourcing and project-based workforce solutions.
On behalf of our client, a global Pharmaceutical company in Bern, we are looking for a Quality Control Qualificaiton and Validation Specialist.
General Informantion:
Job Type: Contract
Job duration: 6 Months with possible extension
Job location: Bern
Start date: 10.06.2024 (ASAP)
End date: 31.12.2024 (extendable)
Main Responsibilities
● Archival of QC Analytical equipment's electronic data according to Pharma regulations, site procedures and IT policies
● Definition of the validation strategy and compliance activities required for archival of electronic data
● Coordination of computerized system qualification and validation activities within the Quality Control department
● 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
Who we are looking for
● 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, ...)
● Strong understanding of the process of electronic data archival within a GMP environment
● Good understanding of analytical technologies
● Good IT knowledge
● 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
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23
