QP / RP consultant

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QbD’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD. We are always looking for the next QbD’er in Quality.
 

 
What do we expect from you as a QP / RP consultant ?

  • Responsible for ensuring that medicinal products are manufactured, tested and released in compliance with EU regulations at our clients in the pharmaceutical industry.
  • Responsible for the regulatory compliance of the pharmaceutical products throughout their whole life cycle.
  • Involved during inspections and audits from the government (e.g. FAGG or FDA) and clients (e.g. supplier audit).
  • Oversee the quality management system to ensure that a robust system is in place for managing quality issues.
  • Both the QP and the senior Quality consultant manage various projects within highly innovative environments in the life science industry. This can range from one large scale project to combining 3 to 4 different projects at the same time.
  • Manage and coach project consultants/team members with a multidisciplinary background.
  • Draw up, review or approve documentation related to the Implementation of a Quality Management System (ISO9001:2015, ISO13485:2016 or according to ICH Q10/Eudralex Vol.4)
    • QMS harmonization for medical device, farma, food, other, …
    • Gap remediation towards FDA or EU GMP legislation/guidance
    • QA process improvement projects
    • GMP, GCP or GLP readiness projects
    • Roadmap to CE marking for medical devices or clinical trial submission support
  • A true QbD’er can be recognized by the following qualities:
    • Resilient: Your strong and positive attitude helps you overcome any challenge
    • Hungry for knowledge: You are always open to learning
    • No nonsense mentality: you can be straightforward in a respectful way
    • Innovative: You are constantly looking for new and better solutions
    • (Not too) serious: your job is serious, but you don’t take yourself too seriously.
 

What’s in it for you?  

  • QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
  • Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. 
  • As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
  • Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 
  • 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 done!

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!

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Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.