The role of MSAT Validation Specialist involves ensuring the quality and reliability of biopharmaceutical manufacturing processes.
This is a challenging position that requires strong analytical and problem-solving skills, as well as excellent communication and project management abilities.
About the Job
* Salary: 80-100%
In this role, you will be responsible for preparing validation documents, owning the process validation including communication with customers, reviewing and approving of process characterization documents, and more.
You will work closely with different teams within the organization and with regulatory agencies to ensure compliance with regulations.
This is a great opportunity for someone who wants to make a meaningful difference in the life sciences industry.
Key Responsibilities
* Prepare validation documents according to procedure and regulatory guidance.
* Own the process validation including communication with customers.
* Review and approve of process characterization documents.
* Responsible for validation assessment on changes and deviations.
* Prepare and maintain a documented continued process verification plan.
* Author, assess, and approve Product Quality Reviews (PQRs).
Key Requirements
* A Master's or Ph.D. degree in Chemistry, Biotechnology, Life Sciences, or related field, or equivalent experience.
* Experience in project management, preferably in MSAT, Operation, Quality, and Compliance.
* Ability to work on different tasks simultaneously and in a timely manner.
About Us
We are a global leader in life sciences operating across three continents.
Our products and services have a positive impact on millions of people worldwide.
We respect and protect our people and our environment, and we strive to achieve business results ethically.