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Qualified Person (QP) in Netherlands

Baker Finn Recruitment

As QP, you are end responsible for certifying and releasing the produced batches of medicine. Your main goal is to ensure that every batch of medicines are produced, examined and stored according to relevant legislation and marketing authorizations.

Requirments

  • WO degree, in the field of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology (according to article 51 of the European Commission’s directive 2011/83/EC)
  • Fluent in English is essential
  • 6 months-2 years of relevant work experience as a QP
  • Required to pass all the offered GMP and GDP courses
  • Basic knowledge of and experience with MS Office programs
  • Experience in a Pharmaceutical Production environment is desirable
  • At least 6 months of acquired practical experience within this or another company with a GMP license in order to be permitted to release batches

Quality Tasks

  • Monitoring the adherence to the requirements of the Good Manufacturing Practice (GMP)
  • Creating, operating and maintaining the quality management system
  • Responsible for evaluating and approving manufacturing documentation and Batch Journal, as well as keeping it for the prescribed time
  • Responsible for checking that Batch Journals are complete prior to the release
  • Ensure that products which do not meet requirements are not distributed
  • Responsible for releasing batches of produced medicines for clinical use
  • Responsible for the safe storage of the batch journals and reference and retention samples
  • (co-)Coordinate site inspection by national authorities
  • Final approval of manufacturing documentation and other GMP documents

Control

  • Responsible for performing internal audits and external audits at sites of contract manufactures
  • Monitor, give guidance, as well as give the final approval for deviations, CAPA’s and Change Controls

Operations

  • Monitoring the adherence to the requirements of the Good Manufacturing Practice (GMP)
  • Responsible for evaluating and approving manufacturing documentation and Batch Journal, as well as keeping it for the prescribed time
  • Responsible for checking that Batch Journals are complete prior to the release
  • Ensure that products which do not meet requirements are not distributed
  • Responsible for releasing batches of produced medicines for clinical use
  • Responsible for the safe storage of the batch journals and reference and retention samples
  • (co-)Coordinate site inspection by national authorities
  • Final approval of manufacturing documentation and other GMP documents

Systems

  • Creating, operating and maintaining the quality management system
  • Responsible for performing internal audits and external audits at sites of contract manufactures
  • Monitor, give guidance, as well as give the final approval for deviations, CAPA’s and Change Controls

Core Competancies

  • Innovative: Ability to think in terms of desired outcomes, not just reactive, quick solutions. Continuously looking for process improvement, develop better, faster, or less expensive ways to do things. Poses stimulating questions and thinks off the beaten track. Approaches situations from different angles to arrive at new insights. Is willing to experiment with new methods to solve existing problems or carrying out existing tasks. Stimulates others to come up with new ideas.
  • Dedicated: Supports others around them by removing obstacles and providing resources. Encourages others to act in line with the culture and goals of the organization. Feeling connected to the organization and encouraging others to do so. Puts the joint result above own result. Thinks along with regard to suggestions for improvement.
  • Caring: Encourages people around him/her to help others and do so in an empathic way.
  • Accurate: Is alert to (possible) deviations in own and other people's work. Delivers the discussed result on time and gives feedback in time if this does not work out. Encourages others to handle details carefully and effectively and guides others to adjust the working method to avoid mistakes in the future.
  • Decisive judgement: Makes thoughtful and timely decisions, takes actions with consideration of different interests, and follows through with concrete actions. Takes full responsibility for decisions made.Planning and organization: Makes concrete and measurable planning arrangements with colleagues/employees. Coordinates the use of people and resources. Ensures that others can monitor the progress of projects and activities.
  • Problem solving ability: Quickly gets to the essence of complex problems. Actively searches for possible causes and different angles of approach. Sees mutual coherence and draws logical conclusions. Identifies trends, risks and consequences of possible solutions.
  • Work independently: Searches for solutions and leaves no stone unturned. Encourages others to first solve problems or obstacles themselves when identifying them. Dares to make decisions and take actions on a tactical level. Stick to personal beliefs, ideas and proposals to arrive at an assessment, even when there is pressure to adapt. Set an example and guides others so that they are able to manage themselves, takes control, and takes responsibility.

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