QA Operations Specialist

QA Operations Specialist

Start: ASAP

Contract: Temporary - 9-month assignment
Location: Breda Area, Netherlands (Onsite - 100%)
Hours: Full-time, shift-based (currently 3 Shifts → 5 shifts in October 2026)
Sector: Radiopharmaceutical / GMP / Quality Assurance

About the Role

We are seeking two QA Operations Specialists for temporary 9‑month at a leading global healthcare organization focused on radioligand therapies and GMP production.

These roles support the operational QA activities on-site, with a strong emphasis on timely and compliant batch release, documentation oversight, deviation management, and real-time decision-making in a highly regulated environment.

Key Responsibilities

• QA review and support for the batch release process
• On-site QA oversight during production operations
• Complete document lifecycle management & batch archiving
• Release of incoming materials
• Visual Monitoring during unannounced inspections
• Review and approval of SOPs, work instructions & protocols
• Support deviation investigations and timely closure
• Review of OOS, OOT, OOE, and system suitability investigations
• Support CAPA & change control execution
• Assist during audits, inspections, and improvement initiatives

Who We're Looking For

• Bachelor's degree or equivalent (Life Sciences, Chemistry, or related field preferred)
• GMP knowledge and experience in QA or regulated environments
• Strong documentation discipline & attention to detail
• Risk-based decision-making under time pressure
• Strong communicator and team collaborator
• Fluent English (spoken & written)

Preferred:

• Experience with radiopharmaceuticals, radiation, or PET production

Shift Schedule (Shift system evolves from 3 → 5 shifts in October 2026)

Shift Times (8-hour shifts, each incl. 1 × 30 min break):

• Early Shift: 06:30-15:00
• Late Shift: 14:30-23:00
• Night Shift: 22:30-07:00

Shift Allowances

• Daytime: 0%
• Morning: +20%
• Evening: +30%
• Night: +40%
• Weekend: +40%

Let op: vacaturefraude

Helaas komt vacaturefraude steeds vaker voor. We waarschuwen je voor mogelijke misleiding:
* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).
* Twijfel je over de echtheid van een vacature of contactpersoon? Neem dan altijd rechtstreeks contact met ons op via de officiële contactgegevens op onze website.

Important: job fraud

Unfortunately, job fraud is becoming more common. Beware of such scams:
* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.
* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.