• For one of our international clients in the pharmaceutical industry we are currently looking for a

Environmental monitoring and qualification specialist (m/f)

Vertragsart: Freiberufler

Auftragsnummer: A362-665

Startdatum: 01.10.2018

Projektdauer: 31.04.2019

Einsatzort: Norddeutschland


Ihre Aufgaben:

  • Responsible for achieving compliance with requirements including mitigation of determined gaps.
  • “hands dirty” approach: executes all work required to achieve compliance, including authoring of all relevant documents (protocols, reports, SOPS, etc), and training.
  • Serves as the subject matter expert for the sterile topic applying advanced theory, technical principles and expert judgment.
  • Support the team and team lead in achieving the team compliance objectives.
  • Ensures that the compliance approach and associated documentation is endorsed.

Ihre Qualifikationen:

  • At least 5 years’ experience in Human Health sterile manufacturing and/or sterile compliance.
  • Experience in FDA regulated environment.
  • Subject Matter Expert in the sterile topic.
  • Proven ability to author GMP documentation right first time.
  • Excellent teamwork skills.
  • Excellent communication and training skills
  • Project experience and ability to work independently (self-starter)
  • Ability to operate in a global environment with a high level of diversity and different cultures.
  • Fluent in German and English language.