QUALIFIED PERSON/QUALITY ASSURANCE MANAGER

Požadované vzdělání:

Požadované dovednosti:

Požadovaná praxe:

Platové ohodnocení:

Popis pozice:

Summary/Purpose of the position

Tasks and responsibilities of GDP Qualified Person, main point of contact for SÚKL (for GDP activities). Responsibility for the tasks related to the design, implementation and maintenance of CZ and CEA Cluster Quality Management System, mainly GxP areas (GDP, GVP, Regulatory, GCP).

Main Responsibilities/Job Expectations

  • Qualified Person for Distribution in CZ

The QP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The QP should carry out the duties in such a way as to ensure that the Ipsen Pharma s.r.o can demonstrate GDP compliance and that public service obligations are met:

  • Ensure that the provisions of the license are observed
  • Ensure that the operations do not compromise the quality of medicines
  • Ensure that a quality management system is implemented and maintained
  • Focus on the management of authorised activities and the accuracy and quality of records
  • Ensure that initial and continuous training programmes are implemented and maintained
  • Coordinate and promptly perform any recall operations for medicinal products
  • Ensure that relevant customer complaints are dealt effectively
  • Ensure that suppliers and customers are approved
  • Approve any subcontracted activities which may have the impact on GDP
  • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
  • Keep appropriate records of any delegated duties
  • Decide on the final disposition of returned, rejected, recalled or falsified products
  • Approve any returns to saleable stock

Ensure that any additional requirements imposed on certain products by national law are adhered to

Management of the CZ Quality Management System (QMS)
  • Foster quality culture
  • Drive initiatives on continuous quality improvement
  • Maintain and develop an effective QMS
Manage all QMS processes to meet the requirements of GxP guidelines, Global Quality and local regulations
  • Generate quality documentation including SOPs, Quality Manual, Quality Technical Agreements, Training Matrices
  • Manage an appropriate records maintenance program, so that records are identified, preserved and easily retrievable throughout the retention period
  • Support stakeholders from different business areas with generation of quality documentation (SOPs and related documents)
  • Contribution to the CEA cluster Quality Management System  
  • Generate and contribute to the management of quality documentation and appropriate records related to the CEA cluster QMS
  • Proactively cooperate with Local Quality Responsibles in other CEA Cluster countries on the above
  • Audit and Inspection readiness
  • Manage the preparation and facilitation of regulatory inspections and Global Quality audits in CZ
  • Maintain the Wholesaler Dealer Authorization in CZ
 
  • Complaint Management CZ, SK

Maintain and ensure complaints management in CZ and SK using global system (Trackwise

 

 

 

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Kontaktní osoba

PHDr. Petr Kovanda

PHDr. Petr Kovanda