CCS BV

Extensive experience in managing deviations and root cause analysis, ensuring effective implementation of Corrective and Preventive Actions (CAPA) to address quality issues, reduce reoccurrence, and promote continuous improvement within GMP-regulated environments.

A proven track record in preparing and leading organizations through regulatory inspections conducted by FDA and EMA. Expertise in aligning operations with regulatory requirements, ensuring documentation and practices are audit-ready, and navigating the complexities of regulatory expectations to achieve successful outcomes.

Deep understanding of the validation process, including equipment, process, and computer system validations. Ensures that all systems maintain compliance and efficiency throughout their entire lifecycle, from initial qualification to decommissioning, while adhering to Good Automated Manufacturing Practice (GAMP) standards.

Proficient in drafting, reviewing, and maintaining Standard Operating Procedures (SOPs), ensuring that they meet regulatory standards and are easily interpretable by staff. Focuses on creating comprehensive, clear, and actionable SOPs that promote operational consistency and high-quality standards across all processes.

Dedicated to fostering a proactive quality culture within organizations by promoting employee engagement and accountability. Ensures that quality principles are embedded in day-to-day activities, encouraging teams to prioritize compliance, risk management, and continuous improvement as part of their operational ethos.