Job Description:
About the Role
This exciting opportunity is available for a skilled MSAT Validation Specialist to join our team in Visp, Switzerland. As a key member of our Bioconjugates organization, you will be responsible for manufacturing process validation in biopharmaceutical plants.
Key Responsibilities:
* Develop and implement validation strategies, ensuring compliance with regulatory guidelines and company procedures.
* Collaborate with customers to ensure effective communication and project delivery.
* Evaluate and approve process characterization documents, guaranteeing accuracy and quality.
* Analyze and approve changes and deviations, maintaining consistency with regulatory requirements.
* Create and maintain continued process verification plans, promoting continuous improvement.
* Author, assess, and approve Product Quality Reviews (PQRs), ensuring compliance with regulatory standards.
About You
To succeed in this role, you will require:
Requirements:
* A Master's or Ph.D. degree in Chemistry, Biotechnology, Life Sciences, or a related field, or equivalent experience.
* Experience in project management, preferably in MSAT, Operations, Quality, and Compliance.
* The ability to interact effectively with various teams within an organization and with regulatory agencies, such as Swissmedic and FDA.
* The capacity to work on multiple tasks simultaneously and meet deadlines.
Why Join Us?
At our organization, we strive to make a meaningful difference in people's lives by developing innovative life sciences solutions. We value our employees' creativity, skills, and dedication, offering a dynamic and challenging work environment that encourages growth and development.
We Offer:
A collaborative and supportive team environment.
The opportunity to work on complex problems and develop new ideas in life sciences.
A chance to improve lives worldwide and make a positive impact.