Jobid: 632580429117401048 (0.0503)
QA Specialist Quality Oversight
As QA Specialist Quality Oversight, you play a key role in maintaining and continuously improving our Quality Management System (QMS). You ensure compliance with GMP and GDP regulations, support inspection readiness across the organization and affiliates, and provide expert quality oversight in a regulated pharmaceutical environment. You will work closely with internal stakeholders, external partners, and affiliated companies to strengthen quality culture and drive operational excellence.
Your tasks
Ensure a robust, compliant, and inspection-ready Quality Management System.
Manage quality records and quality processes, including deviations, CAPAs, and change controls.
Coordinate and support Quality Management Reviews (QMRs), including preparation, reporting, and follow-up of actions.
Develop, maintain, and oversee internal and external audit programs using a risk-based approach.
Perform audits as lead auditor and ensure effective follow-up of audit findings.
Support regulatory inspections and maintain continuous inspection readiness.
Monitor and report quality KPIs and provide quality performance insights to management.
Act as a quality partner for affiliates and support alignment of local quality systems with regulatory requirements.
Deliver training on GDP, quality systems, and quality-related topics.
Draft and maintain quality procedures, policies, and standards.
Represent Quality Assurance in cross-functional projects and continuous improvement initiatives.
You have
Bachelor’s degree in a relevant scientific or life sciences discipline.
Relevant experience within the pharmaceutical industry.
Experience working with quality systems, including deviations, CAPA management, and change control processes.
Strong knowledge of GMP and GDP requirements.
Certified GMP/GDP auditor with at least two years of internal and external auditing experience.
Excellent communication skills in Dutch and English.
GCP and GVP auditor certification is an advantage.
GDP Responsible Person certification is an advantage.
Lees hier meer…
Deel deze vacature:
