QA Scientist – Microbial Biotech (Fixed-Term)

AGC Biologics; Søborg; On-site; DKK 540,000 - 760,000; Full time

Job summary

AGC Biologics in Søborg, Denmark, is seeking a QA Scientist to join the QA Microbial team on a fixed-term maternity cover of nine months. The role focuses on ensuring quality assurance of manufacturing activities and patient safety across the biotechnological production processes.

You will review and approve technical documents (BPRs, change controls, deviations, CAPAs, DS/MPRs, risk assessments), support SOP development, and assist withQuality Agreement negotiations and client audits in a

Qualifications

• Master’s degree in a science field.
• Experience with QA and GMP in biopharma.
• Fluency in written and spoken English.
• Experience supporting manufacturing at a drug substance or product site.

Responsibilities

• QA review and approval of technical documents (BPRs, change controls, deviations, CAPAs, DS specs, MPRs, risk assessments).
• Help develop and improve SOPs within the department.
• Assist with Quality Agreement negotiations with clients and support client audits.

Skills

QA experience

GMP knowledge

English fluency

Education

Master's degree in a science field

Job description

AGC Biologics in Søborg, Denmark, is seeking a QA Scientist to join the QA Microbial team on a fixed-term maternity cover of nine months. The role focuses on ensuring quality assurance of manufacturing activities and patient safety across the biotechnological production processes.

You will review and approve technical documents (BPRs, change controls, deviations, CAPAs, DS/MPRs, risk assessments), support SOP development, and assist withQuality Agreement negotiations and client audits in a