This role entails being responsible for managing validation aspects associated with the introduction of new products into the site. The scope covers a broad range of activities required to ensure successful implementation and regulatory compliance throughout the product lifecycle.
Key service activities include:
* Validating and documenting support for formulation, filling, shipping, and packaging processes.
* Executing and documenting of urgent quality investigations.
* Performing comprehensive risk assessments and defining appropriate mitigation measures.
* Supporting and implementing process and system changes related to product introduction.
* Providing overall project management, including coordination, planning, issue resolution, and progress reporting.
Qualifications:
* Master's degree in a scientific field such as Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
* A perfect command of Dutch and good knowledge of English (written and oral) are required.
* Strong communication and interpersonal skills, team player and demonstrate an organized, accurate, and quality-conscious work approach.
* Analytical skills, problem-solving abilities, and a good technical writing style are crucial.
* Experience in executing validation projects and proficiency in planning and project coordination are highly valued.
* The project often requires a pragmatic, proactive, and results-focused individual who can take the lead and work both independently and collaboratively.
* Experience in a Good Manufacturing Practices (GMP) environment and familiarity with risk assessment and validation processes are important.
* Flexibility for shift work may be required for certain projects.