Are you a Compliance Scientist looking for a new career opportunity? Do you enjoy working cross functional and have exposure to all –levels internal clients? Our Quality Systems team is growing and we are looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.

Do you have a compliance systems background and want to be responsible for the maintenance of the quality systems and processes for deviation, CAPA, and change management?  Do you enjoy collaborating with internal partners, to prepare and provide guidance on execution of the processes referenced? This may be just the role for you!

Our Quality Systems team is expanding and we are looking for a diligent and customer-oriented Compliance Scientist to join our team in Copenhagen. 

About Quality Systems
Quality Systems is an important part of the Quality organization. You will be joining a diverse team of eleven highly qualified colleagues, all with several years of experience within quality assurance.

The Quality Systems team is responsible for maintenance and development of our quality systems for deviation, CAPA, change management, training management, and document control.  We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers, as well.

The role:
The Compliance Scientist plays a critical role in the maintenance of the quality systems and processes for deviation, CAPA, and change management. The role collaborates actively, on a daily basis, with internal customers from all GMP areas across the site, providing guidance on execution of the processes referenced. This role is also heavily involved in current site backlog reduction initiatives, as driven by the site’s Quality Plan.
 
Principal responsibilities:
For the deviation, CAPA, and change management processes:
  • Partner with internal and external stakeholders to implement and optimize the current electronic platform for process management.
  • Educate internal stakeholders on the current processes.
  • Support the development and implementation of a sustainable strategy for record workload management, including backlog remediation and prevention.
  • Support the site lead in global discussions relating to process development, implementation, improvement, and harmonization.
  • Provide front and/or back office support for internal and external audits and inspections.

Education/Training:

  • Master’s degree in Chemistry, Biochemistry, Pharmacy, or similar
  • Preferably 3+ years’ experience working in a cGMP environment.

Soft skills and competencies:

  • Strong written and verbal communication skills.
  • Actively develops and maintains strong professional relationships building trust and respect across the organization
  • Lead through influence, effectively build alignment and collaborate with multiple stakeholders
  • Facilitate organizational change related to quality systems across multiple functions

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.

Application
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

Want to keep posted about our growth and to learn more about our company?
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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.

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