Validation & qualification consultant
What are your responsibilities 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.
- Your expertise can also be called upon for the validation of the latest gadgets, such as an RNA printer.
- 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).
- You will work in companies within the 'life sciences': the pharmaceutical, biotech, medical device, cosmetic and healthcare industries, ranging from the big pharma companies to the newest and most innovative start-ups.
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).
- You have extensive experience (at least 5 years) within the field of validation and within the life science industry.
- Hands-on mentality: performing validation tests yourself doesn't scare you off… This way you seamlessly fit in with our value #gettingthingsdone.
- You have a strong technical knowledge. Knowledge of or a first experience with CSV and quality management systems is a plus.
- Humor… We take JOY very seriously.
- You are a barrel full of new ideas and initiatives.
- As a multitasker you accelerate in coordination and planning.
- You are result and quality oriented.
- You communicate well with:
- Stakeholders at the customer's
- Our internal team: sales, HR, management, knowledge manager, competence center leaders
- Your QbD colleagues of all levels of expertise
- Quality is your number one concern.
- Teamwork… makes the dream work.
What does QbD offer 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:
- Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
- A company with a clear strategy and ambition
- We've got your back! 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.
- Standing still means going backwards. 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.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a monthly basis. A comedy night or quiz night? Nothing is too crazy for us!
- In short… We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!