About Us
We are a consulting and engineering organization with over 19 years of experience supporting clients throughout the entire lifecycle of biotechnology, pharmaceutical, and device products.
With a team of more than 750 Life-science experts, Consultys Switzerland provides unparalleled technical and scientific expertise, allowing us to serve both French-speaking and German-speaking Switzerland from our agencies in Lausanne and Basel.
We pride ourselves on combining people and performance, creating an environment where individuals can grow and thrive.
Our core values of Respect, Recognition, and Transparency have been the foundation of our success and the driving force behind our history.
Job Description
Responsibilities:
* We require a CQV Coordinator to join our team in Stein, focusing on equipment installation coordination (20%), IQ/OQ/PQ protocol drafting, execution, and documentation according to cGMP requirements.
* This role involves validation activities, including facilities, utilities, validation life cycle, technical documentation, process, GAP analysis, risk assessment, and more.
* The successful candidate will execute IQ/OQ and PQ for equipment, systems, and utilities, write reports on completed validation activities, and identify efficiencies in the validation program approach.
* They will also apply lessons learned, stay informed of industry regulatory changes, and perform quality systems activities, including document management, change control, non-conformities, and CAPAs.
* In addition, this role requires writing and/or revising procedures applicable to engineering activities and supporting the engineering group in preparing the validation, requalification, and maintenance program.
Your Profile:
* A bachelor's degree in a science or technical field is required, along with advanced-level pharma industry experience (5-10 years).
* Excellent technical writing skills and the ability to document work thoroughly, accurately, and timely are essential.
* Strong written and oral communication skills, as well as the ability to work interdepartmentally effectively, are necessary to carry out daily duties.
* Excellent organizational and time management skills are also required.
About the Role
Seniority Level
Associate
Employment Type
Full-time
Job Function
Business Consulting and Services, Biotechnology Research