Driven and dedicated professional with more than 6 years’ experience leading and providing consultation on compliance and quality assurance as well as significant experience in interpreting regulatory needs and client expectations. Preparing all required documents from qualification documents to dossiers.
Instrumental in the evaluation and implementation of processes and tools used to drive continuous quality improvement of data and processes. Ability to design and implement methodologies for root cause analysis of critical quality and compliance-related issues. Strong experience in aseptic manufacturing and associated systems and qualification (WFI, Clean Steam- Systems).
Areas of Expertise
• Aseptic manufacturing
• Qualified Person
• Advanced analytical methods • Regulatory Affairs
• Quality Assurance
• Quality Management Systems • ISO 9001; 2001/83/EC,
• Quality Control
• GMP, GDP