Saibalaji Lakkoju

Highly accomplished QA professional with 16+ years of experience in Quality Assurance, Validation, and Product Formulation within the pharmaceutical industry. Expert in navigating regulatory inspections (US FDA and global health authorities) and ensuring compliance with GxP and ICH standards. Proven ability to implement robust quality systems, drive continuous improvement, and foster strong client relationships. Seeking a challenging leadership role to leverage expertise in enhancing quality performance and achieving organizational goals.

Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

• Played a pivotal QA role in the successful completion of the Aurobindo green field project within established timelines, securing approvals from US FDA, WHO-GENEVA, MCC-SOUTH AFRICA, NDA-UGANDA, ANVISA, INFARMED- PORTUGAL, TGA-AUSTRALIA, TFDA – TAIWAN, KFDA-KOREA, enabling rapid market entry.
• Identified critical gaps on the shop floor and provided actionable recommendations to top management, resulting in significant improvements in manufacturing processes and quality control, enhancing overall operational efficiency.