QA Compliance Expert

LausanneTemporär2018-07-10Master / Universität
Spring Life Sciences is looking for his client a:

QA Compliance Expert

Responsibilities

  • Develop applicable global quality risk management documentation as e.g. policies, standards, procedures and work practices.
  • Support development of risk assessment tools and related documentation.
  • Support the implementation of global processes for quality and compliance risk identification, assessment, control, review, tracking, communication, resolution and escalation as applicable.
  • Develop and support implementing global and functional QRM training processes and associated documentation including appropriate GMP policy statements, global standards, standard operating procedures and work practices (including developing courses, curriculums, train-the-trainer programs, and delivering training).
  • Develop and support delivery of training on the use of quality risk management methods and tools to ensure consistency in application.
  • Work in close collaboration with the other risk management functions to ensure consistency in risk assessment, management, mitigation and continuous review.
  • Other responsibilities as assigned by management


Qualifications

  • Relevant college or university degree required. Bachelor of Science degree in a science or technical field. (Chemistry, Biology, Pharmacy, Chemical Engineer, etc.);
  • 5-10 years relevant work experience (pharmaceutical industry)
  • Excellent written & oral communication skills (English is a must. Other languages: French, German a plus).
  • Knowledge and thorough understanding of international regulatory directives (FDA, EMA, MHRA, PMDA, QSR, ICH, PIC/S) and Risk Management principles with the ability to interpret and apply requirements.
  • Must have Expert authorship in quality documentation, technical documents. -
Authorship in Risk Management documentation a plus.
  • Advanced understanding of tools and approaches to assess and mitigate risk.
  • Demonstrated oral and written communication skills including presentations, able to communicate effectively with internal and external cross functional teams.
  • Proven ability to work effectively with cross-functional stakeholders in a complex, changing global environment.
  • Ability to work proactively and independently
  • Knowledge of most common office software (Microsoft Office).


Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -072018-292885