Qualification in Active Pharmaceutical Ingredients (API) & eVAL (EW)
Posted: 15 Jun 2022
Qualification Engineer in Active Pharmaceutical Ingredients (API) & eVAL (EW) Do you have experience in Qualification engineering, especially in Active Pharmaceutical Ingredients? Do you speak German? Do you want to be a part of a world-leading medical device and pharma company? Then you should read the following lines! Our client, based in Basel is looking for a Process Engineer who has experience in Qualification engineering , if you are the right fit don’t hesitate to apply Tasks & Responsibilities: Creation of qualification plans/reports for the phases DQ-IQ-OQ-PQ
• Implementation of qualifications in the phases DQ-IQ-OQ-PQ
• Creation of QPP / MQP (Qualification Project Plan / Master Qualification Plan)
• Carrying out requalifications to check the qualified status of existing systems.
• Evaluation of the data integrity of production plants based on a given catalog of questions
• GMP-compliant documentation of the work carried out
• Assumption of an essential role as a contact person in the current rollout for the support of the current system as a power user (1st level support of the users).
• Development of proposed solutions in the eVAL training system for various use cases.
• Completed studies in one of the fields of EI&C technology, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology
• At least 3 years of professional experience with qualifications in systems in the API environment
• Professional experience in GMP regulated Working Environment
• od IT skills (MS Office, ogle Sheets, Gmail & Calendar)
• Very good kledge of spoken and written German and good kledge of English is required
• Ability to work in a team, initiative, self-responsibility, careful and speedy way of working