Senior Quality Operations Lead with Flexible Hours & Growth

Prothya Biosolutions Belgium BV

Netherlands

Remote

EUR 52,000 - 75,000

Full time

12 days ago

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Job summary

Prothya Biosolutions Belgium BV seeks a QA specialist to lead batch release and QA operations under GMP. You will review batch records, support CAPA and RCA, and ensure audit readiness across QC and QA processes.

You will supervise QA Officers, liaise with OMCL, handle deviations (OOS/OOL/OOT) and participate in investigations and inspections. Dutch and English required; 40h weekly with flexible hours.

Qualifications

Bachelor/Academic degree in Life Sciences or Pharmacy.
HBO > 2 years experience or MSc.
GMP knowledge; experience with biologics, drug substances and aseptic manufacturing preferred.
Experience with Trackwise, MasterControl, SAP or similar.

Responsibilities

Batch record review and preparation for QP batch release.
Supervise QA Officers and communicate with OMCL.
Physical release in the product warehouse.
Support deviations, CAPA, RCA activities and OT/OS/QMS reviews.
Assist QA engineers in investigation and closure of Product Quality Complaints.
Handling of returned goods and change controls.
Review and timely closure of CAPA actions.
QA training on deviations and related systems.
Support regulatory audits as SME during inspections.
Prepare monthly quality metrics and QA reviews.

Skills

Analytical thinking

Clear communication

Proactive approach

Dutch language

English language

Education

Bachelor/Master in Life Sciences/Pharmacy

HBO > 2 years or MSc

Tools

Trackwise

MasterControl

SAP or similar

Job description

You will supervise QA Officers, liaise with OMCL, handle deviations (OOS/OOL/OOT) and participate in investigations and inspections. Dutch and English required; 40h weekly with flexible hours.

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