Sr. QA Manager - PV and GDP

Location Switzerland
Discipline: Pharmaceutical
Job type: Freelance
Contact name: Ivan De Marcos Ospino

Contact email: i.ospino@panda-int.com
Job ref: 19594
Published: about 1 month ago

SPECIFIC DUTIES & RESPONSIBILITIES:  

Primary tasks

Quality Assurance (QA)

  • Supports Responsible Person for QA in Denmark (Iceland) and Norway including maintenance of wholesale dealer’s authorisations for the client.
  • Acting as a GDP contact point for the competent authorities, inspections and audits.
  • Ensure that QA activities are performed in compliance with current GDP, national and EU-regulations
  • Ensuring appropriate handling of Deviations/CAPAs and Change Control as well as secure necessary corrective measures are put in place
  • Responsible for narcotic substances in Denmark and Norway including maintenance of authorisations for the company to handle euphoriant substances

Other mandatory tasks

  • GDP and GVP responsibilities
    • Comply with GDP and GVP principles and fulfil the obligations in the relevant documents of the quality management system. This includes reporting of all deviations and changes affecting GxP areas.
    • Report on all adverse events, other safety issues, incidents, product quality issues and suspicions of falsified medicine according to the relevant SOPs.
  • Legal responsibility
    • Comply with all company legal and compliance SOPs, policies and relevant procedures.

 

 

Main contacts:

  • Customers (HCPs, pharmacists, patients)
  • Health authorities in Denmark, Iceland and Norway
  • GDP/GVP service providers
  • Consultants
  • Colleagues in the company

 

Requirements:

  • The health market and Governmental policy
  • Industry regulatory environment and relevant Codes of Practice
  • Profound understanding of pharmacovigilance, quality assurance (GDP) and compliance hereunder GDP and PV legislation and guidelines
  • Experience of GxP environment (especially with quality and safety assurance)
  • Understanding of development, manufacturing and launch of medicinal products
  • Qualification in Pharmaceutical Medicine is desirable
  • Understand the businesses strategy and goals and how this translates for the Medical function


Workload: 20-30h per week

Location: Hybrid – Requires travel to Denmark.

Starting date: September

Duration: Until the end of the year (4 months)