QA Scientist — Microbial GMP | Batch Release Lead

agcbio; København; On-site; DKK 550,000 - 700,000; Full time

Benefits offered by this job

Maternity cover

Job summary

AGC Biologics is seeking a QA Scientist to join the QA Microbial team in its Denmark based site. The role focuses on quality assurance of microbial manufacturing of drug substances and cell banks, ensuring compliance with GMP, EU GMP, 21 CFR and ICH guidelines.

The successful candidate will lead QA reviews, coordinate with internal resources, and support SOP development while engaging with international stakeholders to safeguard product quality and patient safety.

Qualifications

• Master's degree in life sciences or equivalent.
• Experience in QA and GMP within the biopharmaceutical industry.
• Fluent English communication and collaboration across international stakeholders.

Responsibilities

• QA review and approval of technical documents (BPRs, change controls, deviations, CAPAs, DS specifications, master production records, risk assessments).
• Support development and improvement of department SOPs.
• Liaise with internal/external stakeholders to resolve issues and ensure patient safety and product quality.
• Negotiate Quality Agreement terms with clients and support client audits.

Skills

Quality Assurance

GMP compliance

QA review

Biopharma exp

Education

Master's degree in life sciences

Job description

AGC Biologics is seeking a QA Scientist to join the QA Microbial team in its Denmark based site. The role focuses on quality assurance of microbial manufacturing of drug substances and cell banks, ensuring compliance with GMP, EU GMP, 21 CFR and ICH guidelines.

The successful candidate will lead QA reviews, coordinate with internal resources, and support SOP development while engaging with international stakeholders to safeguard product quality and patient safety.