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Marco Simon
HR Manager
Movianto

Qualified Person

O&M Movianto is dedicated to being the preferred European healthcare solutions partner with best-in-class quality for the pharmaceutical, biotech, medical device and diagnostic industries. We offer outsourcing services along the supply chain such as warehousing, transportation, active temperature control logistics as well as Value Added Services; order to cash and sourcing.


The company has more than 1,900 teammates are managing over 275,000 pallet locations spread over a network of 20 wholly owned warehouses in 11 European countries.

O&M Movianto is part of Owens & Minor Inc., headquartered in Richmond, Virginia, USA



We are searching for our site in Oss:


Qualified Person (fulltime)



The Qualified person is responsible for the releases of the manufacturing activities within Movianto NL and ensures manufacturing is performed in line with cGMP.

The Qualified Person will be registered as Qualified Person on the manufacturing license

(fabrikantenvergunning / GMP license).This person will in teamwork with QA manager further improve the QA department.

The employee has the responsibility to act safe and environmentally conscious. All activities are performed conform to GDP, GMP, ISO 9001 and ISO 13485.



YOUR RESPONSIBILITIES?

                              

  • Ensuring manufacturing activities in line with the Cgmp.
  • Ensuring releases of manufacturing activities at Movianto NL and responsible for GMP compliance statements for manufacturing activities.
  • Ensuring that an effective quality management system is operating for GMP activities.
  • Ensure that all regulatory obligations of the manufacturing authorization holder are fulfilled.
  • Provide regulatory input related to manufacturing authorization updates.
  • Provide or approve GMP training.
  • Provide QA and GxP consultancy if needed.
  • Perform and/or Participate inspections and audits.
  • Handle Change Controls Request and Approving GMP critical Change Control Requests if needed.
  • Ensure traceability of the manufactured batches.
  • Apply high ethical standards and professional conduct with clients and with the Healthcare Authorities.
  • Handle complaints and deviations if GMP related.
  • Improve the Quality Systems within Movianto NL.
  • Performs self-inspections according to the self-inspection plan Movianto NL (If trained, internal certified) .
  • Safety: The employee must abide to any prevention measure and measure of security and safety. The employee must at all times treat safety as a matter of priority for themselves and others. Any unsafe situation must be reported immediately to the prevention consultant.
  • Environment: the employee must behave within Movianto environmentally aware and will contribute to environmental objectives. VB: paper & print management; energy-saving measures such as turn of the lights ; sorting of waste.
  • GxP: each employee will at all times abide to the GxP rules and immediately report situations in which GxP is compromised.

  


YOUR PROFILE?

 

  • PharmD degree in Pharmacy
  • Minimum of 1 year experience in a GxP area
  • Good written and verbal communication skills (NL / EN)
  • Qualified Person on manufacturing license (IGJ; EU Directive 2001/83/EC)

WHAT WE OFFER?


Are you interested working for a young and dynamic international organization and do you have the qualifications and skills we require? Please send your CV with motivation letter in English to HR-NL@owens-minor.com t.a.v. Marco Simon, HR manager.





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