Analytical Transfer Lead / Documentation Quality Assurance (m/f/d)

Basel  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung



Analytical Transfer Lead / Documentation Quality Assurance (m/f/d)

Reference: -en
Start: asap
Duration: 10 MM++

Main tasks:
  • Ensure that processes, documentation and systems are in place and followed to allow effective analytical method transfers for Commercial site-to-site transfers (including CPO testing labs) in close collaboration with QC
  • Creation and oversight for review and approval of transfer documentation (e.g. method transfer plans and reports) in the applicable document management systems (i.e. Subway) in close collaboration with the sending and receiving sites
  • Preparation and oversight of material and sample shipments required to support analytical method transfers and comparative testing
  • Routinely asses test methods and testing monographs and proactively sustain compliance of all analytical transfer activities with current official regulations, pharmacopeias, QM, QD, GOP, STD and SOP relevant for analytical method transfers
  • Provide statistics and test results evaluation/reporting to support decision-making during method transfer. Support investigations (OOS/OOE/OOT, deviations) and provide support for troubleshooting, when needed
  • Responsibility for the stability program support associated with transfers incl. results evaluation, reporting and trending, if applicable


Main qualifications
  • Relevant experience in Biologics QC/AS&T or Quality Function with experience in a commercial manufacturing site
  • Profound experience in biological and physico-chemical protein analytics incl. Subway and ESOPS knowledge
  • Ability to influence people, negotiate and communicate
  • Strong project management skills
  • Good and proven ability to analyze, evaluate and ensure cGMP compliance with analytical transfer requirements of analytical method transfers incl. HA requirements such as i.e. FDA, ANVISA)
  • Fluent English and German (oral and writing)


Main advantages:
  • You will work in an international environment



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

My contact person:
Emina Mustafic

Referencenumber:


Make contact:
Email:
Start
ab sofort
Dauer
10 MM++
(Verlängerung möglich)
Von
Hays AG
Eingestellt
27.02.2021
Ansprechpartner:
Kerstin Werner
Projekt-ID:
2059162
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren