QA Consultant – Batch Review (On‑site, Hillerød)

About the role

An international life‑sciences environment is seeking a hands‑on QA Consultant to support operational Drug Substance QA during a peak period. The role is on‑site in Hillerød and focuses on batch record review and manufacturing support in a GMP setting.

Key responsibilities

• Review and approve batch records both on the shop floor and within QA systems.
• Support real‑time QA activities in a live manufacturing environment.
• Act as QA partner to manufacturing and MSAT, resolving batch record queries.
• Ensure GMP compliance while taking a pragmatic approach to issue resolution.
• Maintain high quality standards while working to tight timelines.

Required profile

• Minimum 5 years QA experience within pharmaceutical manufacturing.
• Strong experience in Drug Substance manufacturing.
• Proven experience reviewing and approving batch records.
• Solid understanding of GMP and manufacturing processes.
• Degree in Pharmacy, Biotechnology, Chemistry or a related field.
• Detail‑oriented with a strong quality mindset.
• Self‑driven and able to work in a fast‑paced environment.
• Pragmatic, solution‑focused and collaborative across QA and manufacturing teams.

Required skills

• GMP knowledge
• Batch record review
• Drug Substance manufacturing experience