QA Officer – Sterile Fill/Finish

About the role

A sterile fill/finish CDMO on the Leiden Bio Science Park is converting its main filling line from RABS to isolator technology to meet Annex 1 (2023). You join the QA team of eight as the QA Officer assigned to that line: batch record review, deviations and change controls for the project and, once the line is requalified, day-to-day release support for two international clients.

Your responsibilities

• Review executed batch records for the sterile filling line and prepare release packages for the QP
• Own deviations from initiation to CAPA effectiveness, including classification and root cause facilitation
• Assess change controls for the RABS-to-isolator project against the validated state
• Review environmental monitoring excursions and APS (media fill) documentation with QC micro
• Support client audits and the 2027 IGJ inspection preparation

What you bring

Must-haves

• 3+ years QA at a sterile / aseptic manufacturing site
• Working knowledge of Annex 1 (2023): CCS, first-air, intervention classification
• Hands-on deviation and CAPA ownership with root cause tools
• Fluent English; Dutch not required

Nice-to-haves

• Isolator or RABS qualification exposure
• CDMO multi-client experience
• Lyophilisation process knowledge

What's offered

• €55,000–68,000 gross per year, 8 % holiday allowance
• Pension (2/3 employer-paid), 27 days leave
• 30 % ruling support for eligible internationals
• Annex 1 and lead auditor training budget

About the company

A contract manufacturer with around 300 staff, three filling lines and clients in the EU, US and Japan. English-language quality system; the QA team is six nationalities.