ARE YOU PASSIONATE ABOUT PROCESS STANDARDIZATION AND OPTIMIZATION? DO YOU HAVE EXPERIENCE IN DEFINING DOCUMENTATION STANDARDS IN A REGULATED ENVIRONMENT? AND DO YOU GET ENERGIZED BY TAKING THE DRIVER SEAT IN THE IMPLEMENTATION OF NEW DOCUMENTATION STANDARDS AND IMPROVEMENTS?

At AGC Biologics we are looking for you who has several years’ experience in manufacturing and thrives setting up the standard for manufacturing documentation, while ensuring full compliance with regulatory requirements. And of course, someone who wants to be part of a team with the mission to improve patients’ lives.

QUALIFICATIONS

• You have a Master’s degree in Pharmacy, natural sciences or similar
• More than 5 years’ experience working in manufacturing and deep understanding of batch records, workflows, and processes
• Solid experience in GMP and regulatory requirements regarding documentation
• Experience defining and implementing standards for manufacturing documentation
• Experience in project planning, coordination and implementation would be advantageous
• Excellent English communication skills both written and spoken
• Good communication, presentation, and interpersonal skills to engage with others
• Master basic Microsoft Office 365 applications (Word, PowerPoint, Forms)
  On a personal level, you are a self-starter with a collaborative and service mindset who is comfortable working independently but also able to collaborate with others. You thrive in a multicultural and busy work environment. You listen, you evaluate and you rarely accept the first “no” you get. As you have a structured approach to your work, you can juggle several tasks while prioritizing your efforts optimally by keeping the bigger picture in mind. You are a good team player who is able to prioritize and manage multiple tasks effectively.

You will be part of the Manufacturing Readiness and Compliance department, a newly established function within manufacturing. The department has the responsibility to enable standardization and optimization of the manufacturing processes via process knowledge, data insights and innovation.

As our new GMP Specialist, you will:

• Be responsible for developing strategies for MPR standardization and global harmonization , as well as ensuring compliance with regulatory requirements
• Support the organization with technical skills and developing the capability across manufacturing by assisting and training all parts of the organization
• Assist the organization in transforming documents to new standards
• Participate in compliance projects to assist the organization creating high quality standards and templates
• Develop training material and train the organization in MPR process and how to use the template
• Trend and monitor use, compliance, efficiency and improvements to templates and procedures