Senior Specialist QMS

NeuchatelTemporaireChimie, Pharma, Biotechnologie2019-07-03Master / Université
We are recruiting on a long term contract an experienced QA specialist to support the implementation of the QMS

Senior Specialist QMS

Your Responsibilities

  • Supports the Director, Quality Systems, in the deployment, harmonization and continuous improvement of Quality Management Systems in relation with Global/Multisite and Local initiatives.
  • Works closely With QA Documentation and Training Team to ensure Documentation and Training processes scalability and efficiency within an evolving environment. This includes: Training Curriculum structure & assignment strategy across department & sites, user groups design, documentation management and approvals enhancement, creation/simplification of procedures/ instructions where relevant...
  • Will interact with Sites QA Compliance representatives in the frame of Quality systems improvement initiatives, activities follow-up, meetings preparation (data collection/ metrics) and assigned actions completion.
  • May be involved and contribute to any potential QMS IT systems enhancement initiative /change projects.
  • Will assist Director, Quality systems, in creation or update of multi-sites /local documents associated with Documentation / Training or other relevant Quality systems, in compliance with regulatory requirements and company policies.
  • Provide support in the deployment of Global Quality Management Review requirements and ensure process alignment across manufacturing sites.

Your Profile

  • At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.
  • BS or MSc in Science or related field.
  • Thorough understanding of cGMPs and FDA regulatory requirements.
  • Excellent interpersonal, collaborative and organizational skills.
  • Ability to work independently, yet effectively in a team environment.
  • Very good written & oral communication skills (French/English).
  • Experience in deployment, harmonization and improvement of Quality Systems (Documentation, Training, Deviation, CAPA, Quality metrics...) at a strategic and operational level (including procedure writing/ training material design)
  • Ability to focus attention to details.
  • Investigational and QA problem solving skills
  • Project Management skills is a plus.
  • Knowledge of office software (Microsoft Office).

Votre contact

Etes-vous intéressé(e)? Merci de postuler directement en ligne.