Senior QA Leader: Safeguarding Life-Saving Medicines

Tjoapack; Etten-Leur; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Professional development

International environment

Ownership culture

Annual raises

Competitive compensation

Zusammenfassung

Alcami is a leading global CDMO with a site in Etten-Leur, NL, focusing on packaging and supply chain services for medicines. As a Senior Quality Assurance Specialist, you will safeguard product quality, patient safety and regulatory compliance across the site, partnering with customers, suppliers and labs to drive continuous improvement.

You will independently plan, coordinate and execute QA activities, serve as a main contact for stakeholders, and help maintain our Quality Management System

Qualifikationen

• Master's degree in pharmaceutical-related subject.
• GMP/GDP-regulated environment experience.
• Audits, inspections, CAPAs, deviations, root cause analysis experience.
• Experience managing supplier and customer relationships while maintaining regulatory requirements.
• Strong analytical, organizational and problem-solving skills.
• Excellent communication and the ability to explain complex topics clearly.

Aufgaben

• Plan, coordinate and execute a broad range of QA activities.
• Coordinate supplier qualification and supplier audits.
• Prepare, negotiate and coordinate Quality Technical Agreements.
• Manage customer audits and regulatory inspections.
• Review and approve QA activities such as procedures, deviations, CAPAs, change controls and effectiveness checks.
• Coordinate external stability studies from protocol to results.
• Provide QA guidance to cross-functional teams and stakeholders.

Kenntnisse

QA in pharma

Regulatory knowledge GMP/GDP

Audits & inspections

CAPA & deviations

Root cause analysis

Stakeholder management

English proficiency

Dutch language (advantage)

Ausbildung

Master's in pharmaceutical science

Bachelor's with QA experience

Tools

QMS experience

Jobbeschreibung

Alcami is a leading global CDMO with a site in Etten-Leur, NL, focusing on packaging and supply chain services for medicines. As a Senior Quality Assurance Specialist, you will safeguard product quality, patient safety and regulatory compliance across the site, partnering with customers, suppliers and labs to drive continuous improvement.

You will independently plan, coordinate and execute QA activities, serve as a main contact for stakeholders, and help maintain our Quality Management System