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QA Lead for Manufacturing Operations

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), dedicated to improving life quality by bringing new biopharmaceuticals to market.

We deliver 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.

This role offers an exciting opportunity to join our Quality Assurance team, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment.

Your main objective will be to ensure that our production facilities and laboratories comply with current GMP standards at all times.

Your daily responsibilities will include:

  • Reviewing and approving technical documents, such as change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, qualification protocols, and reports.
  • Conducting regular audits in GMP areas to ensure adherence to quality standards.
  • Maintaining open communication with internal and external stakeholders to resolve issues and clarify points of concern.
  • Contributing to the development of standard operating procedures (SOPs) for qualification, calibration, maintenance, cleaning, and other facility and engineering activities.

To succeed in this role, you must have a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality.

You should possess:

  • A science-based degree.
  • Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
  • Prior biopharmaceutical experience is desirable.
  • A thorough understanding of 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.