QA Consultant (m/w) – Freelance

  • Position zu besetzen ab 18. Juli 2018
  • Permanent-ID OCR-FL-2018-1122
  • Branche Biotechnologie
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 3x
  • Kategorien Beschäftigungsform, Biotechnologie, Branche, Freelance/Contracting

Tasks

  • review the implementation and efficiency of quality and inspection systems / ensures alignment with Animal Health QMS
  • Responsible for achieving compliance with the MSD 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

Skills

  • At least 10 years’ experience in Human Health sterile manufacturing and/or sterile compliance
  • Experience in EMA and/or FDA regulated environment and how to prepare for an inspection
  • Subject Matter Expert in aseptic manufacturing
  • Proven ability to author GMP documentation correctly at first attempt
  • 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

 

Additional Information

Location: Burgwedel

Project start: July 2018

Duration: 4 month until October 2018

Availability: 4-5 days/week

 

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