Overview
Auditor QA Systems Jobs in Amsterdam, North Holland, Netherlands at Prothya Biosolutions
Title: Auditor QA Systems
Company: Prothya Biosolutions
Location: Amsterdam, North Holland, Netherlands
Prothya Biosolutions is seeking a QA-S External Oversight Auditor to ensure the highest standards of quality across our supply chain and service providers. This role is essential to maintaining our GMP compliance and ensuring our partners meet the rigorous standards expected of a pharmaceutical leader. If you thrive in a dynamic, fast-paced environment and have a passion for quality assurance, we want to hear from you.
Key Responsibilities
Quality Assurance & Oversight:
Monitor compliance with GMP regulations and internal policies, focusing on Quality Oversight of suppliers and customers.
Act as a key QA contact for suppliers and customers, driving quality initiatives and resolving issues.
Manage quality contracts with external partners, oversee supplier complaints, and lead qualification and performance assessments.
Ensure timely responses to audit findings and provide regular management reports.
Auditing:
Plan and execute internal and external audits for Prothya’s suppliers, customers, and service providers, both locally and internationally.
Lead GMP audits, coordinating cross-functional teams and providing guidance during audits.
Prepare for and facilitate external audits at Prothya, including documentation management and follow-up on previous findings.
Continuous Improvement & Compliance:
Keep up to date with industry trends, regulatory changes, and best practices in GMP and Quality Oversight.
Identify risks and opportunities for improvement, ensuring Prothya remains compliant and competitive.
Draft and assess audit reports, ensuring alignment with Prothya’s Quality Management System (QMS).
Collaboration & Communication:
Collaborate with internal teams, including Procurement, Regulatory Affairs, and Quality Assurance, to align on quality objectives.
Maintain open communication with stakeholders, providing updates on quality activities and sharing actionable insights.
What We’re Looking For
Bachelor-level education in a relevant field such as pharmaceutical sciences or quality management.
Certified Lead Auditor credentials are a must.
At least 5 years of experience in a similar role, ideally within a cGMP environment.
Previous experience in the pharmaceutical sector is highly desirable.
In-depth knowledge of audit methods, pharmaceutical regulations, and quality systems.
Strong organisational skills with a keen eye for detail.
Excellent communication and interpersonal skills to work effectively across teams and stakeholders.
A proactive, solutions-oriented mindset with a passion for maintaining the highest standards of quality.
Why Join Prothya Biosolutions?
Make a meaningful impact on patients’ lives by contributing to life-saving therapies.
Be part of a company that values collaboration, innovation, and excellence.
Access opportunities for professional growth and continuous learning.
Work in a culture that prioritises quality and compliance as core values.
Competitive compensation and benefits package.
Ready to Join the Prothya Team?
We’re looking for talented individuals who share our dedication to improving patient outcomes. Let’s shape the future of healthcare together.
