Laboratory System Analyst EN/GE
On the behalf of one of our clients in pharmaceutical industry a Laboratory System Analyst. The role implies collaborating with stakeholders to ensure laboratory are compliant with Data Integrity guidelines by implementing a Data Audit Trail Review process. With proactivity and self-responsiveness. This is a 12-month contract, ideal start date mid-September, based in Bern.
Main responsibilities:
â?¢ Assess laboratory instruments and software with Data Integrity guidelines.
â?¢ Implement Data Audit Trail Reviews for laboratory instruments and software
â?¢ Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with different departments
â?¢ Manage local and global qualification and validation projects.
â?¢ Collaborate with internal and external stakeholders
â?¢ Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.
Your profile:
â?¢ University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
â?¢ 3+ yearsâ?? experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
â?¢ First project management experience in an operational environment.
â?¢ Knowledge of regulations on computerized systems and laboratory automation
â?¢ Strong written and verbal communication skills in German and English
â?¢ Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.
â?¢ Ability to work independently and as a team member in a high-performance environment.
Interested about this position? Feel free to send your application Write an email
Main responsibilities:
â?¢ Assess laboratory instruments and software with Data Integrity guidelines.
â?¢ Implement Data Audit Trail Reviews for laboratory instruments and software
â?¢ Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with different departments
â?¢ Manage local and global qualification and validation projects.
â?¢ Collaborate with internal and external stakeholders
â?¢ Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.
Your profile:
â?¢ University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
â?¢ 3+ yearsâ?? experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
â?¢ First project management experience in an operational environment.
â?¢ Knowledge of regulations on computerized systems and laboratory automation
â?¢ Strong written and verbal communication skills in German and English
â?¢ Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.
â?¢ Ability to work independently and as a team member in a high-performance environment.
Interested about this position? Feel free to send your application Write an email
À propos de l'entreprise
