Sai Naidu

Dedicated and detail-oriented Quality Assurance professional with 3 years 9 months of experience progressing from In-Process Quality Assurance (IPQA) to Senior Executive QA (QMS) within pharmaceutical and cosmetic manufacturing environments. Skilled in monitoring manufacturing processes, conducting line clearance, handling deviations, and ensuring strict adherence to cGMP, SOP, and ISO 22716 standards. Seeking to contribute my expertise to a reputed pharmaceutical organization focused on product quality, regulatory compliance, and continuous improvement.

Senior Executive – Quality Assurance (QMS) at Kamson Health Care Pvt. Ltd., a subsidiary of Himalaya Wellness Company (2024-05 – Present)

• Led issuance and review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Ensured timely issuance, review, approval, and archiving of QA documentation in compliance with GMP and ISO 22716:2007 standards.
• Implemented and maintained the Quality Management System (QMS), including document control, change management, OOS, deviation handling, and incident reports.
• Managed deviations, incident reports, and change control records as per QMS procedures.
• Supported internal and external audits by preparing necessary documentation and ensuring audit readiness.
• Reduced deviation recurrence by improving root cause identification and CAPA tracking.
• Contributed to achieving zero non-compliance findings in internal audits.

Executive – In-Process Quality Assurance (IPQA) at Kamson Health Care Pvt. Ltd., a subsidiary of Himalaya Wellness Company (2022-09 – 2024-05)

• Conducted In-Process Quality Assurance (IPQA) checks in manufacturing and packing areas to ensure compliance with GMP standards.
• Verified and maintained line clearance, batch production records (BPR/BMR), and material traceability for each batch.
• Oversaw dispensing and usage of raw and packing materials, ensuring accuracy and documentation compliance.
• Performed routine calibration of balances in packing, filling, and manufacturing areas as per SOP requirements.
• Reviewed logbooks, manufacturing records, and dispensing reports for accuracy and consistency.
• Coordinated with production and QA teams to ensure real-time monitoring and corrective action implementation.
• Reported daily quality observations and assisted QA management during audits and regulatory inspections.

B. Pharmacy – Sri Siddhartha Pharmacy College, Nuzvid (2022)

Intermediate (Bi.P.C) – Vignan Junior College, Kaikaluru (2018)

SSC – P.V.C.M.Z.P.H School, Rurapaka (2016)