The tenant of the function ensures product expertise to support investigations and change management.
DUTIES AND RESPONSABILITIES
·Manage the day-to-day quality assurance activities related to Supplier Management, including supplier qualification, audits, monitoring, change notification.
·Write, review and approve documentation to ensure compliance with cGMP and applicable regulations.
·Manage, assess, approve and monitor Supplier Audit program.
·Ensure Supplier audit are performed according to plan.
·Responsible to perform Supplier Audit
·Establish and maintain written instructions for supplier management.
·Manage, assess and approve deviations, investigations and CAPA plans.
·Review, assess and approve implementation of changes.
·Maintain eQMS supplier and material list.
·Represent QA function in supply chain routine operational meetings.
·Operate in close proximity with warehouse, supply chain and manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events.
·Ensure regulatory inspection readiness in area of responsibilities.
·Support any Heath Authorities inspections (Swissmedic, FDA and other International Health Authorities) in relation to area of expertise and responsibilities.
·Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
REQUIREMENTS
·Academic degree in natural or applied sciences (pharmacy, chemistry, biotechnology, engineering).
·Previous experience in Quality Assurance for pharmaceuticals at manufacturing sites.
·Previous experience in Supplier Management and audit activities.
·Thorough knowledge in cGMP and international regulatory requirements.
·Experience in health authorities inspections.
·Strong analytical and problem solving skills.
·Ability to make pragmatic and compliant decisions.
·Strong result orientation and committed team member.
·Good verbal and written communication skills with well-structured communication.
·Fluent in French written and spoken (the company language) as well as in English.
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.
Learn more at:
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
