QC Method Validation Expert

2 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

As a QC Method Validation Expert, you will play a critical role in ensuring the accuracy and reliability of our analytical methods. You will work closely with our cross-functional teams to develop and implement methods that meet regulatory requirements, participate in operational planning, and ensure all activities follow cGMP guidelines.

The QC Department is responsible for maintaining the highest standards of quality and compliance in our production processes. In this role, you will be responsible for method validation, SOP development, and regulatory compliance.

Key Responsibilities:

  • Develop and implement analytical methods for QC and research purposes
  • Collaborate with colleagues to develop and implement efficient QC processes
  • Participate in method validations and technical transfers
  • Ensure continuous compliance with cGMP regulations

Requirements:

  • Masters degree in Life Sciences or related field
  • Minimum 3 years of experience in a GMP environment, preferably in QC
  • Experience with method validation, SOP development, and regulatory compliance
  • Excellent communication and teamwork skills

About Us:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service to our clients and partners. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.



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