QA Specialist - Change & Document Control

Our client, a prominent pharmaceutical organization, is seeking a professional to oversee their change control program and manage document control systems. This role focuses on maintaining high quality standards and ensuring regulatory compliance through technical expertise and process improvement.

• Administer the change control program and manage local procedures and specifications within the document control system.
• Lead initiatives to ensure compliance with quality standards, company policies, and safety regulations.
• Develop solutions for complex database problems and technical challenges.
• Author and update standard operating procedures while assisting cross-functional teams with documentation.
• Identify performance trends and report improvement opportunities to management.
• Execute batch release once all compliance and procedural requirements have been verified.
• Investigate customer complaints and provide data for annual drug product reviews and quality reports.

• You bring 5+ years of experience in Quality Assurance, specifically in change control, document control, and batch release.
• You possess expertise in authoring SOPs and managing technical specifications within a quality framework.
• You have a strong background in complaint investigation and reporting, including Annual Drug Product Reviews (ADPR).
• You're experienced in solving database problems within quality or document management systems.
• You bring a thorough understanding of GMP, safety, and environmental compliance.
• You're proactive and solution-oriented.
• You are fluent in English.

Nice to Haves

• Experience with information mapping technology.
• Knowledge of Dutch.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.