Consultant für Laboraufgaben
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As a member of the QA department, you will participate in the development, implementation and continuous improvement of procedures and systems ensuring adherence to cGMPs. Your work focuses on the analytical laboratories. Your main responsibility is the QA support of the QC laboratories, their equipment and infrastructure. You will work very close to the QC teams. Your support analytical method transfer and aspects related to QC instruments (analytical equipment qualification).
Key Responsibilities:
Ensure QA oversight for analytical method transfer / validation in dedicated customer projectsEnsure the continuous implementation of the regulatory requirements and Lonza global policies in the laboratories in Ibex VispReview and Approval of the Validation Master Plan for the QC Equipment qualification o Review and Approval of equipment SOPsDesign of the equipment specific qualification together with QCReview and approval of qualification documents o Represent the Quality Unit in cross-functional teamsAssist the QC department in developing programs and SOPs to meet current industry standards, internal and external regulatory requirements
Key Requirements:
Bachelor, Master degree or PhD in Analytical Science or related field of Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit (QA, QC)Strong background in cGMPBroad knowledge in QC / analytics (testing of biomolecules preferred)Sound experience in representing Quality and Compliance in projectsExperience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA )Excellent verbal, written and interpersonal communications skills o Excellent organizational & self-management skills o Strong team orientation and solution- oriented way of workingFluency in English, German would be a great advantageSthree Switzerland is acting as an Employment Business in relation to this vacancy.
