Senior Scientist, Quality Assurance

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.

Would you like to be a part of AGC Biologics' growing success?
We are looking for a QA Scientist with a strong interest in qualification of GMP Facilities, Equipment and Computerized Systems.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. We deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.

Position Overview:
As the QA Scientist, you will be a vital member of a highly motivated, multidisciplinary team. Your daily responsibilities will include:

  • Overseeing the Quality Assurance review and approval of all technical documents, including but not limited to:
    • Change Controls
    • Deviations
    • CAPAs
    • Risk assessments
    • SOPs
    • Validation Plans
    • Requirements Specifications
    • Qualification Protocols and Reports
  • Conducting GEMBA walks in GMP areas
  • Communicating with internal and external stakeholders to resolve and clarify any points of issue
  • Be part of setting standard for Qualification, Calibration, EM, cleaning and other Facility and engineering activities.

Your Profile:
It is crucial to possess a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality. Our working environment is dynamic and demanding, necessitating the capability to problem-solve, fulfill commitments, and provide a favorable experience for our clients.

Education and Experience:
The ideal candidate should possess the following qualifications:

  • A science-based degree
  • Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site
  • Prior biopharmaceutical experience is desirable
  • Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
  • Experience with the qualification of GMP facilities, equipment, and computerized systems
  • Knowledge of Data Integrity principles
  • Strong decision-making skills and a proactive attitude
  • Excellent written and verbal communication skills
  • Ability to work efficiently in a fast-paced, matrix environment
  • Ability to meet deadlines and effectively manage multiple tasks
  • Flexibility to adapt to changing business needs and priorities.

At AGC, we serve international clients and English is our company language. As such, professional proficiency in both written and spoken English is a requirement.

About The Department:
You will be joining the Quality Assurance department, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment.

The main objective of the team is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines at all times.

Applications:
We continuously assess incoming applications and schedule interviews accordingly. To ensure prompt consideration, please submit your application and resume promptly.

The advertisement will be closed once the ideal candidate has been identified.

Location: Copenhagen Site

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