Manager Quality Assurance (m/w/d) – Freelance – geschlossen

  • Position zu besetzen ab 1. Juni 2019
  • Permanent-ID OCR-FL-2019-1044
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 3x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben

  • Review and Approve Deviations and CAPAs in Quality Assurance Role (initial and final classification, review as Quality Representative, approval)
  • Perform regular meetings to support the Investigation Leads of the operational departments
  • Assure ongoing compliance with the customers requirements
  • Assure ongoing compliance with quality and industry
  • regulatory requirements
  • Develop and implement improvements of the deviation respectively the CAPA site procedure

Anforderungen

  • D. /M.Sc. /B.Sc. in Microbiology, Biology, Pharmacy, or other related sciences.
  • At least 10 years’ experience in Human Health quality assurance, production or quality control
  • Experience in EMA and/or FDA regulated environment and how to prepare for an inspection
  • Subject Matter Expert in Deviation and CAPA management
  • 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.

Zusätzliche Informationen

Standort: Burgwedel

Projektbeginn:  01.06.2019

Projektlaufzeit: 31.03.2020

Verfügbarkeit: 4-5 Tage / Woche

On-site Support: 100%

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