I am a dedicated Quality and Validation professional, with over 4 years of hands-on experience in Quality Assurance, Equipment Qualification, Process Validation, and Cleaning Validation. I bring a strong focus on internal audits and compliance, with a track record of ensuring adherence to ISO standards.

My core competencies include:

•Quality Assurance: Experienced in developing, implementing, and maintaining quality systems, with a strong emphasis on regulatory compliance and continuous improvement.

•Regulatory Affairs: Adept in reviewing and approving change requests for medical device manufacturing across the full Validation lifecycle, complying with internal procedures and ISO 13485 & ISO 14971 requirements.

•Equipment Qualification: Skilled in writing
IQ/OQ, PQ, and RQ protocols for the qualification of equipment and facilities to ensure they meet industry standards and specifications.

•Process & Cleaning Validation: Proficient in creating validation protocols for OSD operations, Bioreactors, and CIP/SIP systems, ensuring manufacturing processes are efficient, effective, and compliant with regulatory requirements.

•Internal Audits: Experienced in leading ISO 9001, 14001, and 45001 internal audits, identifying non-conformances, and implementing corrective actions.

I am also a certified Google Project Management professional and hold a Lean Six Sigma Green Belt certification, demonstrating my ability to manage projects efficiently and implement process improvements. Additionally, my proficiency in Excel (Intermediate level), Gen AI, and Minitab allows me to analyze data effectively and create meaningful reports.

I am passionate about promoting a culture of quality and safety within organizations, always seeking to drive efficiency, reduce risks, and ensure compliance with industry standards.