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.
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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. xjsrcvq Flexibility for shift work may be required for certain projects.