SANTHOS KUMAR PABBARAJU
Assisatant Mnager Quality Assurance
Vizag
Summary
Dynamic pharmaceutical quality professional with 14+ years of experience in Quality Control (QC), Analytical Quality Assurance (AQA), and GMP compliance in API,Formulation pharmaceutical and Biological industries. Experienced in regulatory compliance, audit management, analytical systems, data integrity, CSV activities, OOS/OOT investigations, and team leadership. Proven ability to drive operational excellence and maintain high-quality standards.
Overview
15
15
years of professional experience
1
1
Certification
3
3
Languages
Work History
Assistant Quality Assurance Manager
Shilpa Biocare Pvt Ltd
07.2025 - Current
- Directed end-to-end IPQA activities in pharmaceutical and biological manufacturing operations, ensuring compliance with cGMP and regulatory requirements.
- Managed Analytical Quality Assurance (AQA), stability study-related activities, audit trail reviews, and data integrity compliance in line with ALCOA+ principles.
- Supported Computer System Validation (CSV) activities as per International Society for Pharmaceutical Engineering GAMP 5 guidelines for GxP computerized systems.
- Led investigations related to OOS, OOT, deviations, and non-conformances, and implemented effective CAPA actions for continuous quality improvement.
- Reviewed BMRs, BPRs, line clearance activities, and batch release documentation to ensure GMP compliance and product quality.
- Prepared, reviewed, and implemented SOPs, and managed QMS activities including change controls, market complaints, return goods, risk assessments, and vendor qualification activities.
- Coordinated Management Review Meetings (MRM), prepared quality metrics and compliance reports, and supported inspection readiness and regulatory audits.
- Coordinated GMP and QMS training programs, analytical instrument qualification activities, and collaborated with cross-functional teams to ensure operational and regulatory compliance.
Assistant Manager
PharmCrux GMP Consultancy
10.2024 - 05.2025
- Conducted third-party GMP audits and supported organizations in regulatory compliance.
- Assisted organizations in fulfilling audit and compliance obligations.
Quality control Executive
Laurus Synthesis Pvt Ltd
02.2016 - 10.2024
- Led instrumentation team for HPLC, GC, FTIR, and wet lab operations.
- Implemented operational efficiency and intra-unit compliance improvements.
- Reviewed audit trails and implemented corrective actions.
- Facilitated QMS activities ensuring adherence to regulatory standards.
- Analytical method transfers and method validations execution and monitoring
Research Associate Grade-2
Lupin Ltd
05.2015 - 02.2016
- Streamlined analytical method validation processes.
- Developed wet chemistry techniques and executed analytical method validations.
Quality Control Chemist
Neuland Laboratories
10.2014 - 05.2015
- Performed in-process analysis of raw materials and finished products.
- Conducted stability studies and calibration activities.
Quality Control Associate-3
Laurus Labs Ltd
10.2011 - 10.2014
- Executed wet chemistry analysis and raw material sampling.
- Supported method transfer activities and instrument calibration.
Education
B.Sc - MPC
A.B.R Govt Degree College
Repalle, GunturM.Sc - Analytical Chemistry
Dr. M.R. Appa Rao College
Nuzvid01.2011
Skills
Regulatory Compliance
GMP
Familiarity with analytical processes
Data Integrity
CAPA
OOS/OOT Investigation
Analytical Method Validation
QMS
CSV
Team Leadership
Problem Solving
Effective Communication
Certification
ISO 9001:2015 Lead Auditor (Quality Management System)
Timeline
Assistant Quality Assurance Manager
Shilpa Biocare Pvt Ltd
07.2025 - Current
Assistant Manager
PharmCrux GMP Consultancy
10.2024 - 05.2025
Quality control Executive
Laurus Synthesis Pvt Ltd
02.2016 - 10.2024
Research Associate Grade-2
Lupin Ltd
05.2015 - 02.2016
Quality Control Chemist
Neuland Laboratories
10.2014 - 05.2015
Quality Control Associate-3
Laurus Labs Ltd
10.2011 - 10.2014
M.Sc - Analytical Chemistry
Dr. M.R. Appa Rao College
B.Sc - MPC
A.B.R Govt Degree College