Quality Responsible Person Belux

For a client in the region of Mechelen, we are actively looking for a Quality Responsible Person Belux!

Are you an industrial pharmacist with a first experience and a QP certificate?
Then this might be an interesting opportunity for you!

Make 2018 a very interesting year, and contact me for more information.

Job Description 
Key Responsibilities: 
  • Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled 
  • Ensure adherence to Divisional Quality Manual and provide feedback to QM Chapter owners 
  • Health Authority (HA) interactions and notifications regarding Quality and Supply issues in close collaboration with Regulatory Affairs Belux 
  • Information and interaction with local business and regional Quality Management 
  • Ensure Quality perspective is brought into local business initiatives with Quality impact 
  • Local coordination and execution of product recalls 
  • Primary country contact for Quality 
Responsibilities 
Specific Quality related responsibilities: 
Country Quality Management 
Develop, implement and maintain the local Quality Management System (QMS) 
Applying Quality Risk Management (QRM) principles 
Formal Management Review meetings 
Audits & Self Inspections 
Management of audits and inspections of the local office 
Self-inspection execution, documentation and communication 
Prepare / Review / Approve Responses / Corrective and Preventative Actions (CAPAs) 
Training 
Development and maintenance of local Quality training program 
Ensure Quality training of personnel including assessment of training effectiveness 
Complete trainings as required for role 
Documentation 
Development and keeping records of any delegated duties 
Ensure quality and accuracy of documentation and record retention 
Approve and review local procedures with Quality impact 
Product Quality 
Ensure effective management of Product Quality Complaints (PQCs) including routing the PCQs and samples to the manufacturing sites 
Tracking, trending and signaling of PQCs 
HA reporting of PCQs 
Handling of PQC customer responses 
Handling of suspect Counterfeit, Diversion or Tampering (CDT) including HA notifications 
Coordination of customer temperature excursion assessment 
...
 
Profile 
Profile:
  • Industrial pharmacist
  • Someone who can release
  • 3-5 years’ work experience
Contact Information 

Anneleen De Vos
anneleen.devos@valesta.com
015 21 11 04

Important 

For the full job description, please do not hesitate to contact me!

Application form : Quality Responsible Person Belux

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