Qaulity Assurance Specialist GDP (f/m/d) 24 months

Wien Interim EUR65,000 - EUR75,000 p.a. Home Office

hinzugefügt 29/03/2023

  • international company
  • decision maker

Firmenprofil

In this key Quality role for the Austrian business you will develop and maintain Quality systems, rules, and processes to ensure the fulfillment of internal and external quality requirements related to distribution and logistics processes for our time critical pharmaceutical products.

Aufgabengebiet

  • You will be working with the QA Distribution QMS, to develop, implement and maintain procedures relating to the wholesale distribution activities of distributed products
  • You hold the RP responsibilities for warehouse storage and outbound deliveries of products to end customers in Austria
  • You manage outsourced activities - 3PL, local carriers, including supplier qualification, audits and Quality and Technical Agreements
  • You are responsible for the Quality Risk Management of the wholesale distribution operation and oversee the customer qualification process
  • You assist in developing and delivering training for functions supporting GDP activities
  • You liaise with regulatory authorities regarding activities related to the wholesale distribution activities of distributed products under the WDA
  • You hold the RP responsibilities for returns (final disposition of returned, rejected, recalled or falsified products), product recalls where required and are the Point of Contact for Customer Complaints related to distribution
  • You will perform Self-inspection and Internal Audit and host Quality System Audits (internal and external)
  • You are responsible for Deviations, Investigations, Corrective Actions relating to the wholesale distribution operation and QA support for other GDP activities
  • You will constantly monitor and review our Quality System for effectiveness and implementation of continuous improvement programs

Anforderungsprofil

  • You hold a University degree in pharmacy, human sciences, dentistry or veterinary medicine, chemistry, biology or a related discipline
  • You are eligible to be designated a Responsible Person on a Wholesale Dealer's Authorisation in Germany and were ideally prior designated as a Responsible Person on a Wholesale Dealer's Authorisation
  • You bring a proven relevant professional experience as a Responsible Person in the pharmaceutical industry, preferably in a Distribution or Manufacturing environment
  • You bring fluent Language skills in English and German in written and spoken
  • You bring the experience in dealing with competent authorities
  • You bring strong problem solving skills and an experience in auditing (as auditor and auditee)
  • Your high degree of self-motivation and self-responsibility together with strong influencing abilities help you to work with cross functional and a multinational team

Vergütungspaket

  • Expert & decision maker role in an international company
  • Challenging and varied tasks
  • Attractive salary plus bonus
  • This is a temporary position for 18-24 months with the option of transfer/internal development
  • According to the Austrian Law the minimum salary for the role based on the trade collective agreement (KV Handel) is 60.000 €. The final salary package will be defined based on the successful candidates experience and will very likely be higher
Referenznummer
JN-032023-5997932

Zusammenfassung

Nach Berufsfeld suchen
Life Sciences
Näheres Berufsfeld
Pharmazie
Branche
Healthcare / Pharmaceutical
Ort
Wien
Vertragsart
Temporary
Referenznummer
JN-032023-5997932
Art des Jobs
Home Office