Consultant - Validation & Qualification

Consultant - Validation & Qualification

Consultancy

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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. Your responsibilities: * responsible for the (GxP critical) validation of equipment (autoclaves, production and packaging lines, …), utilities, processes (cleaning, sterilization, …) and software * monitor and ensure that equipment, utilities, qualified areas and processes are compliant (CFR 21 Part 11) * set up and implement validation strategies in accordance with internal procedures and regulations * review and, when necessary, write validation protocols (IQ/OQ/PQ) and effortlessly draw up URSs, risk assessments, test scripts, reports,… * take care of the coordination and execution of projects and introduce less experienced consultants in your field of expertise What do we offer? The QbD group is a healthy and international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package (company car, fuel card, insurances, meal vouchers, ...), we can offer you: * a clear strategy and ambition - our QbDream! * short communication lines, easy decision making & impact - you are heard! * value and data driven company * sustainable relationships - human centric approach * being part of an award winning company More info? https://qbdgroup.com/en/vacancies/validation-qualification-consultant/
QbD Groupbooth 86-87-94-95The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a multinational company with over 480 high-qualified employees and are growing fast as we realise our ambitions of expanding worldwide. Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions: • Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle. • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy. • Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software. • Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities. • Lab Services: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products. • Software solutions & services: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU). • Business & Communications: We help you launch your product to market by providing marketing and communication services, business development support, and sales strategy.

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