Job Summary (Primary function)
Supports the Quality System and related operation activities associated with the development and the maintenance of a Quality Management System for our new green-field large scale API bio-manufacturing facility. Responsibilities include supporting the implementation of a new local Quality Management System according to quality policies, cGMP, Swiss, EU / US FDA Regulations. More specifically this position will participate to the definition and maintenance of the following quality assurance systems: Training, documentation, change control, CAPAs, deviation management, risk management, supplier qualification internal and external audits.
Essential Functions of the Job (Key responsibilities)
• Act as QA Admin and support actively system users in their daily tasks within the different quality systems
• Maintain employee’s initials and personnel onboarding/termination up-to-date
• Responsible for local documents archiving
• Maintain local training matrix and assign training within the e-DMS
• Provide QMS training to users regarding the different Quality Systems (including but not limited to: Good documentation practices, documents creation, Document owner or viewer within the eDMS, etc…)
• Prepare KPIs extract and metrics follow-up to monitor Quality systems health and compliance with cGMP and internal applicable documents
• Prepare business meeting leaded by Quality such as Change control board (organize meeting, prepare agenda, ensure follow-up of actions)
• Participate to document creation for Quality Management system processes in relation with Global organization
• Participate to internals’ audit and maintain internal audit plan and reports
• At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Must speak, read and write in English and French
• Must have minimum experience of 2 years in a biopharmaceutical manufacturing environment
• Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards with Quality Systems is a plus
• Experience in health authorities inspections is a plus
• Ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member
• Excellent written and verbal communication skills.
• Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing
• Experience of Quality Assurance systems
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Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.