Qualified Person IMP and Deputy Technical Director – Lisbon

Ort: Portugal - Lisbon

Ihr Profil

We are currently looking for a Qualified Person IMP and Deputy Technical Director for our office in Lisbon. In this exciting position you will have a dual role as Qualified Person of the secondary packaging and QP release of investigational medicinal products (IMP) and of the Deputy Technical Director of the Lisbon affiliate, distributing CSL Vifor’ products in Portugal. In these roles you will ensure the quality and compliance to the applicable standards of the products manufactured or distributed by Vifor Pharma Portugal S.A. You will closely work together with the CSL Vifor site located in St. Gallen (Vifor International Inc.). In this position, you will be reporting directly to the Qualified Person Group Management Lead, located in St. Gallen, Switzerland.  

Key Tasks
  • QP certification, release and distribution of Investigational Medicinal Products (IMPs) batches produced in the Clinical Trial unit in Portugal, according to the clinical trial application (IMPD) and the related GMP legislation
  • As Deputy RP: Contact with the logistics operator and management of cGDP related activities for the products distributed by Vifor Pharma Portugal
  • Ensure compliance to the current cGMP and cGDP guidelines
  • Release decision regarding the final provisions for IMP batches produced in the Clinical Trial unit according to the regulatory IMP dossier
  • Issuing applicable Qualified Person statements or declarations for IMP
  • Review of batch records and related documentation.
  • Management of QA activities related to the packaging activities (e.g. elaboration/review/approval of SOPs, change controls, deviations)
  • Ensure proper storage and transport of the products including the related batch documentation
  • Management of retention samples
  • Perform training sessions
  • Contact with contract manufacturers of IMPs
  • Elaboration and support of quality agreements compilation
  • Heading authority inspections and participation and support during internal and external audits
  • Elaboration of Quality reports based on risk analysis approach
  • Participate in the maintenance and continuous improvement of the Quality Management System implemented
Qualifications

Minimum Requirements
  • University degree in pharmaceutical sciences
  • Pharmaceutical Industry Specialist title issued by Portuguese Pharmaceutical Society
  • Good knowledge of Portuguese and English (written and spoken)
  • Knowledge of Microsoft tools (e.g.: Word, Excel, PowerPoint)
  • Experience in Pharmaceutical Industry area (minimum 5 years)
Preferred Requirements
  • Experience in pharmaceutical development, pharmacology, pharmacotoxicology and/or related disciplines
  • Experience in auditing (internal, external, hosting inspections) course
  • Experience in working with Quality Software (e.g. Trackwise, SAP, document management systems)
  • Knowledge of statistical tools and Lean 6 Sigma training/qualification

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