Jobs in life sciences

QA consultant/business developer at MindCapture

Ref. QABD
Function: Consultancy in QA projects at customer's site/ customer acquisition
Location: Offices at Ghent, projects at customer’s site (Flanders)

The company:

Talent & content

MindCapture has its offices in Ghent and Antwerp and focuses on innovative environments and future oriented life science talents. We connect people to 21st century company activities that thrive innovation and impact. We provide staffing (talent) and consultancy services (content). 

MindCapture offers a range of services to support companies or healthcare institutions in quality management, data management and business development. The MindCapture consultants are experts in improving or updating actual quality plans (QualityCapture), adding digital layers to internal and external activities (DataCapture) and sharpening business plans for future growth (BusinessCapture). MindCapture's focus is set on labs, CROs, biotech, pharma and medical devices.

Our QualityCapture team consists of experienced quality management consultants who developed their hands-on experience and expertise over the past 15 years. We can help you with a specific quality management request or we can offer a total, customized solution. We are highly skilled in the area of medical devices, medical labs, healthcare services, CRO, pharma and biotech.

Job description:

For our QualityCapture team, we are looking for a QA consultant to strengthen our team. 

  • You will look for new accounts, you make proposals and follow up in needs in the market in order to enlarge our customer base (lead generation, contracting and business development). 
  • You will monitor customer satisfaction as a basis for continous improvement of our service proposal. 
  • You will support in setting up, improving or reorienting the customer’s QMS (as-is analysis, gap analysis and set-up of a fit for purpose QMS)
  • You will validate software (according to GAMP5 methodology), instruments, reagent control, methods and processes. 
  • You will focus on data integrity in compliance with international standards, guidelines, regulations or GxP, as well as document control, training and personnel, complaint and CAPA handling. 
  • You will support risk management. 
  • You support the client in finding the solution that best matches the client’s needs, in alignment with the available time, budget and resources.
  • You will use various tools that are needed to support QMS such as document control and LI(M)S. 
  • You will work in an agile way using a stepwise project management methodology. 
  • You will operate in a pragmatic and solution/result-driven way. 
  • You will perform internal and supplier audits. 
  • You will steer continuous improvement and satisfy processes by setting up and periodically reviewing metrics and KPIs.
  • You will advise and design the management review.  
  • more info: https://www.mindcapture.com/content#quality-capture. 

Requested competences and skills:

  • You have a background in life sciences. 
  • You have a good understanding of QA in medical devices or medical labs or healthcare services or CRO or pharma or biotech. Quality is your passion!
  • You have experience with one or more of following QMS standards: ISO9001, ISO17025, ISO15189, GCP, GCLP, GMP, ISO13485, ISO14791, IEC62403 or EU MDR 2017-745/746. 
  • You have an open mind for business development (can be learnng on the job attitude). 
  • You have a minimum of 3 years of experience with QA. 
  • You are fluent in Dutch and English (speaking and writing). 
  • You are able to take the lead and to motivate others in order to follow QA guidelines.
  • You have strong communicative skills in order to talk with different stakeholders. 
  • You are willing to travel cross Flanders to perform consulting activities at the customer’s site. 
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