Validation & qualification consultant
il y a 1 semaine
Table of Contents
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. Does this description suit you? And would you like to be part of a project and knowledge organization? Then apply nowWhat do we expect from you as a validation & qualification consultant?
You are responsible for the (GxP critical) validation of equipment (autoclaves, production and packaging lines, ...), utilities, processes (cleaning, sterilization, ...) 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 master the writing of validation plans as the best. You review and, when necessary, write validation protocols (IQ/OQ/PQ) and effortlessly draw up URSs, risk assessments, test scripts, reports,... You take care of the coordination and execution of projects and introduce less experienced consultants in your field of expertise. You provide the necessary support during internal and external audits . You help gaining and sharing knowledge within QbD in cooperation with our knowledge manager, competence center leaders and trainers. You stay actively up to date with the latest guidelines, methodologies and trends within your expertise. You are a QbD point of contact with regard to validation and qualification (equipment, packaging, filling,...). You execute quick scans at customers and develop an optimization strategy (gap analysis).Who are we looking for?
You have a master's degree in engineering, technological, pharmaceutical or chemical sciences (industrial engineer, civil engineer, bio-engineer, industrial pharmacist, biomedical sciences, biotechnology/biochemistry, chemistry or a similar scientific study). Preferably, you have experience within the field of validation and within the life science industry. You have a strong technical knowledge . Knowledge of or a first experience with CSV and quality management systems is a plus. A true QbD'er can be recognized by: Resilience : Your strong and positive attitude helps you overcome any challenge Hunger for knowledge : gaining & sharing knowledge on a daily basis A no-BS mentality : you are straightforward in a respectful way Innovative mind: You are constantly looking for new and better solutions Being (not too) serious : your job is serious, but you don't take yourself too seriously.What does QbD Group offer you?
An attractive and complete salary package:
As an award-winning company, we offer you a competitive reward package, including a great work-life blend, ecological mobility plans, well-being solutions, exciting events, training courses, horizontal and vertical career paths (zigzag careers) and much moreBut most of all...
We offer sustainable careers and meaningful connections We are a knowledge based company You'll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, ...Our promise to you:
As an ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals . In short ... We stand for JPEG : Joy in Partnership, going for the Extra mile to Get things doneInterested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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