For our international pharmaceutical customer we are currently looking for a

Projektmanager QA (m/w)

Vertragsart: Freiberufler

Auftragsnummer: A387-666

Startdatum: 01.03.2018

Projektdauer: 30.06.2018

Einsatzort: Norddeutschland


Ihre Aufgaben:

  • Review the implementation and efficiency of quality and inspection systems / ensures alignment with the QMS.
  • Responsible for achieving compliance with the requirements.
  • Document internal audits and other quality assurance activities.
  • Support in developing, recommending and monitoring corrective and preventive actions.
  • Prepare reports to communicate outcomes of quality activities.
  • Coordinate and support on-site audits conducted by external providers.
  • Evaluate audit findings and implement appropriate corrective actions.
  • Monitor risk management activities.
  • Assure ongoing compliance with quality and industry regulatory requirements.

Ihre Qualifikationen:

  • At least 10 years’ experience in Human Health sterile manufacturing and/or sterile compliance.
  • Experience in EMA and/or FDA regulated environment.
  • Subject Matter Expert in aseptic manufacturing.
  • Proven ability to author GMP documentation correctly at first attempt.
  • 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.
  • Language: Fluent in German and English.