We are looking for a Senior Associate Product Quality Compliance to join our Quality Product Compliance team. You will manage PQR/APQR processes and ongoing stability studies to ensure compliance with quality and regulatory requirements. You will also support Change Control activities throughout the product lifecycle.
What Your Day To Day Will Look Like
Product Quality Reviews (PQR): Prepare, review, and maintain annual PQRs, including reports from CMOs, and follow up on CAPAs and quality improvement actions.
Ongoing Stability Studies (OGS): Coordinate annual stability studies with CMOs, review and trend stability data, assess potential OOT/OOX results, and support investigations and annual reporting.
Product Change Control: Manage Change Controls throughout the full lifecycle, including impact assessments, implementation, documentation, and coordination with relevant stakeholders.
Cross-functional Collaboration: Work closely with Regulatory Affairs, Technical Development, Supply Chain, CMOs, and other teams on product quality topics.
Quality Support: Provide quality guidance to internal stakeholders and support quality KPI monitoring, trending, and reporting.
Your Qualifications And Experience
Bachelor's degree / or adequate (e.g. higher technical school in natural science) in a relevant scientific discipline
3 years of experience in a similar role within the manufacturing/quality department/QC of pharmaceutical industry
Experience with Product Quality Report, Ongoing Stability Studies and change control management
Solid understanding of GMP and regulatory expectations (EU, FDA, ICH guidelines)
Strong organizational and analytical skills with attention to detail
Experience working with CMOs and cross-functional stakeholders
Effective communication skills
Fluent in German and English (written and spoken)
professional technical writing skills
Our offer
Open corporate culture with the opportunity to bring in your own ideas
Great opportunities for personal and professional development
Attractive work environment with excellent career opportunities and flat hierarchies
Competitive salary package plus bonus and various benefits
Gross annual salary provided for this function is a minimum of EUR 45.080,- based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.
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Senior Associate Product Quality Compliance in Wien Arbeitgeber: AOP Health
OrphaCare bietet eine herausragende Arbeitsumgebung für Fachkräfte im Bereich klinische Operationen, insbesondere in der dynamischen Stadt Unna. Unsere offene und kollaborative Unternehmenskultur fördert Eigeninitiative und kreative Ideen, während strukturierte Einarbeitungs- und kontinuierliche Weiterbildungsmöglichkeiten Ihre berufliche Entwicklung unterstützen. Genießen Sie umfassende Vorteile und ein Bonussystem, während Sie Teil eines hochleistungsfähigen Teams werden, das sich der Behandlung seltener und komplexer Krankheiten widmet.
