Documentation Specialist [Denmark]

 

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.

About the Role

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 Documentation Specialist, you will:

• Be responsible for standardized development of all document levels in Manufacturing, such us Manufacturing Production Records (MPR), Standard Operating Procedures (SOP), Work Instructions (WOI) and Logbooks
• 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 technical writing
• Trend and monitor use, compliance, efficiency and improvements to templates and procedures

Qualifications

• You have a Master's degree in Pharmacy, natural sciences or similar
• Several years experience working in manufacturing and deep knowledge of the health authorities requirements regarding documentation
• Experience defining and implementing standards for manufacturing documentation
• Experience in project planning, coordination and implementation
• 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) and it would be an advantage if you have experience with automation tools like PowerAutomate

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.

Join an international and agile organization

At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude and we help each other reach deadlines as a team.

Contact and application

For any further questions, your are more than welcome to contact María J Prol García at mprol@agcbio.com. Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company's team and approach are tailored to each of its client's needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.