We are recruiting on a long term contract an experienced QA specialist to support the implementation of the QMSPostuler
Senior Specialist QMS
- 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.
- 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).
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