Quality Engineer (m/w/d) – Freelance – geschlossen

  • Position zu besetzen ab 1. Mai 2019
  • Permanent-ID OCR-FL-2019-1043
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 3x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben

  • Review and Approve documents issued for the aseptic area in Quality Assurance Role (e.g. reports, SOPs, trends, etc.)
  • Review and Approve qualification documents for rooms, equipment and systems in the aseptic area (protocols and reports of URS, DQ, IQ, OQ, PQ, process validation and, fills etc.)
  • Assure ongoing compliance with the customers requirements
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Attendance in meetings related to this

Anforderungen

  • Education requirements: Ph.D. /M.Sc. /B.Sc. in Microbiology, Biology, Pharmacy, or other related sciences.
  • At least 10 years’ experience in Human Health quality assurance, production in aseptic area
  • Experience in EMA and/or FDA regulated environment and how to prepare for an inspection
  • Subject Matter Expert in the field of aseptic production
  • 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:  01.05.2019

Projektlaufzeit: 31.03.2020

Verfügbarkeit: 4 Tage / Woche

On-site Support: 100%

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