Qualified Person

Actavis Dalshraun 1, 220 Hafnarfjörður


Qualified Person

We are currently looking for a talented individual to join our Third Party Quality team in Iceland and step into the role of Qualified Person (QP).

QP is a specialist at the Quality Assurance department with special permission from the regulatory authority to release products to the market.  The QP is responsible for certifying that each batch of product is manufactured according to cGMP and that it fulfils the requirements of the marketing authorization and is in concordance with Eudralex, Volume 4, Annex 16.

Key tasks and responsibilities:

  • Release of products to the market in accordance with EU GMP, Annex 16
  • Review Stability Reports from Contractors and Teva Companies
  • Handling Change Requests
  • Review and approval of Master Batch Documentation, Qualification and Validation Protocols and Reports etc.
  • Handling of Complaints and Recalls
  • Evaluation/approval of deviations and CAPAs
  • Evaluation of OOS results
  • Preparation, approval and maintenance of SOPs
  • Training of employees
  • Approve contractors/internal PQR reports
  • Acting as SME for Audits of contractors and suppliers
  • Quality Support for contractors
  • Contributing to the improvement and maintenance of the Quality system

Qualifications:

  • Master degree in Pharmacy or Natural Science
  • Substantial experience working in a pharmaceutical quality function
  • Knowledge of the principles and guidelines for GMP
  • Strategic and Analytical Thinking, Problem Solving and Decision-Making approach
  • High Accurate Skills
  • Ability to work well in a Team and Independently
  • Good Communications and Planning Skill
  • Fluency in English
  • Good computer knowledge

All CV´s must be in English. For more information regarding the position, please contact Anna Klebert, Anna.Klebert@Tevaeu.com. 

 

Auglýsing stofnuð:

10.05.2019

Staðsetning:

Dalshraun 1, 220 Hafnarfjörður

Starfstegund:

Fullt starf


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