Process Validation Specialist
This role involves manufacturing process validation in biopharmaceutical plants, including process characterization and product quality reviews. The right candidate will be responsible for preparing validation documents, owning the process validation, reviewing and approving process characterization documents, and performing validation assessments on changes and deviations.
The ideal candidate should have a Master or Ph.D. in Chemistry, Biotechnology, Life Sciences or related field, or equivalent experience. Additionally, experience in project management, preferably in MSAT, Operation, Quality and Compliance, is highly desirable. Interaction with different teams within an organization and regulatory agencies would be an advantage.
About the Role
In this challenging role, you will work on various tasks simultaneously and manage your time effectively to meet deadlines. You will also communicate with customers and collaborate with different teams to ensure seamless project execution.
Your Benefits
By joining our organization, you will gain valuable experience in the life sciences industry. You will have the opportunity to work on complex problems, develop new ideas, and contribute to improving lives worldwide. Our organization values its people and the environment, ensuring that every success is achieved ethically.
About Us
We are a global leader in life sciences operating across three continents. Our team focuses on devising ideas that help businesses improve people's lives. We let our employees own their careers and genuinely improve the world through their ideas, big and small.
Key Responsibilities
* Prepare validation documents (study design / writing protocols and reports) according to procedure and regulatory guidance.
* Owning the process validation, including communication with customers.
* Review and approval of process characterization documents.
* Validation assessment on changes and deviations (approval of deviation and changes).
* Maintain a documented continued process verification plan.
* PQRs authoring, assessing, and approving.