Validation & qualification consultant

Validation & qualification consultant

Life science jobs

Information

As an experienced validation & qualification consultant, you have a strong technical background, you enjoy working in regulated environments (GMP) and you ensure that projects are delivered in a qualitative manner. What are your responsibilities? - You are responsible for the (GxP critical) validation of equipment, utilities, processes and software - You monitor and ensure that equipment, utilities, qualified areas and processes are compliant (CFR 21 Part 11) - You set up and implement validation strategies in accordance with internal procedures and regulations - You review and, when necessary, write validation protocols (IQ/OQ/PQ) and draw up URSs, risk assessments, test scripts, reports,… - You take care of the coordination and execution of projects - You provide the necessary support during internal and external audits - You execute quick scans at customers and develop an optimization strategy (gap analysis) Who are we looking for? - You have a master's degree - You have extensive experience (at least 5 years) within the field of validation - You have a strong technical knowledge What's in it for you? - QbD is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:  - A company with a clear strategy and ambition  - Our HR Business Partners follow you closely, giving you the opportunity to shape your career.  - Thanks to our flat organization, we have short communication lines and you can always come to us.  - With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.  - Teambuilding and fun activities are planned on a monthly basis. Interested? Send your CV and motivation letter to jobs@qbd.eu. Want some more info? https://jobs.qbd.eu/en/vacancies/vacancy-validation-qualification-consultant/
Quality by DesignQbD is a partner in the development of qualitative and advances therapies and technologies for the benefit of patients and consumers worldwide. Our knowledge and expertise are at our clients’ disposal. We gained this expertise in following main domains: Quality Assurance Validation & Qualification Regulatory Affairs Projectmanagement & Support Within our two focal points (ATMPs and Medical Devices), we want to take on a pioneering role on a global level and help determine the rules in these two fields. In the short and mid long term, we aim to be present in 5 European countries by starting up QbD subsidiaries or via acquisitions. Additional to those, we also aim to have a few subsidiaries in North-America and Asia. It’s QbD’s ambition to: Being present in all continents worldwide Being present in minimum 5 European countries with more than 50 staff members per country Having an active participation in at least one company dealing with ATMPs and one company dealing with medical devices Being a full service knowledge organization with full expertise in:Process development within ATMPs Quality Assurance and Regulatory Medical Devices Artificial Intelligence/Deep Learning Become, with QbD Software, a premium supplier for the life sciences Having CSV outsourcing/off shoring/near shoring on point

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