Auditor QA Systems
3 weken geleden
Prothya Biosolutions is seeking an experienced External Oversight QA Auditor to join our team. This role is ideal for a dedicated individual who thrives on quality assurance, compliance, and continuous improvement, particularly in a high-impact, fast-paced environment. You’ll be at the forefront of ensuring compliance with Good Manufacturing Practice (GMP) standards across our global network of suppliers and service providers.
Key Responsibilities
- Quality Assurance & Compliance
- Monitor and enforce compliance with GMP standards among suppliers, customers, and internal departments.
- Act as a QA point of contact for internal and external stakeholders regarding quality-related aspects.
- Manage quality contracts and oversee complaint handling, supplier qualification, and performance metrics.
- Auditing & External Oversight
- Plan, lead, and execute internal and external audits, including those with international suppliers, raw material providers, and blood collection centres.
- Prepare Prothya for external audits by organising documentation, coordinating with departments, and setting up front- and back-office procedures.
- Perform risk assessments and continuously improve audit processes.
- Collaboration & Communication
- Collaborate with cross-functional teams, including Regulatory Affairs, Procurement, and Quality Systems.
- Provide updates and recommendations on quality activities, ensuring clear communication with stakeholders and effective follow-up on audit outcomes.
- Continuous Improvement
- Drive internal process improvements, focusing on efficiency and compliance.
- Participate in or lead training sessions to elevate internal audit practices, support colleagues, and share industry best practices.
Who You Are
You are a seasoned QA professional with an unwavering commitment to quality and a flexible, proactive approach to problem-solving. You can balance the travel demands of external auditing (up to four audits per month) with internal process improvement projects. You’re an excellent communicator with a knack for collaboration across various departments, and you bring a calm, constructive approach to high-pressure situations.
Qualifications
- Education: HBO level (or equivalent) in a relevant field.
- Experience: Minimum five years in a comparable role within a GMP-regulated environment.
- Certification: Lead Auditor certification.
- Skills: Knowledge of audit methods and quality systems, strong risk assessment capabilities, and proficiency in internal/external communication.
Additional Requirements
- Willingness to travel up to 40% of the time, including occasional extended stays abroad.
- Fluent in Dutch and English.
- Resilience and a calm, measured approach in handling the complexities of a fast-paced, sometimes demanding environment.
What We Offer
At Prothya, we’re committed to fostering a workplace that supports personal and professional growth. We offer competitive benefits, travel opportunities, and the chance to be a part of a team that values quality, compliance, and continuous improvement.
Ready to join us in setting the highest standards in Quality Assurance? Apply today
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