Siva Prakash Thota
Site Head- Quality Assurance
Visakhapatnam,AP
Summary
Dynamic and results-driven Quality Leader with over 15+ years of experience in OSD and nasal manufacturing environments. Specializes in translating complex regulatory requirements from regions including the US FDA, Russia, Canada, and Romania into streamlined, high-efficiency production practices. Achieved zero-critical audit outcomes through successful Production Remediation and Operational Excellence initiatives, while significantly reducing batch release cycle times via digitalization and Lean Six Sigma methodologies. Committed to fostering a culture of continuous improvement and operational efficiency within manufacturing teams.
Overview
16
16
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Site QA Head at FTO SEZ Process Unit-01
Dr. Reddy's Laboratories Ltd.
03.2024 - Current
- Architect and implement manufacturing systems that embed cGMP and Quality by Design (QbD) into the daily production flow for OSD and nasal products.
- Drive site-wide Lean Daily Management (LDM) to optimize resource allocation, and ensure 100% adherence to production schedules, while maximizing equipment uptime.
- Direct the lifecycle of critical operational documents, including Site Master Files and Validation Master Plans, to maintain a constant state of 'Audit Readiness' for global regulators.
- Lead high-stakes production remediation plans to bridge technical gaps, ensuring manufacturing continuity following US FDA, MHRA, and EMA inspections.
- Oversee OOS, OOT, and deviations using FMEA and Fishbone analysis to identify shop-floor root causes and implement permanent CAPAs.
- Act as the primary operational lead for Product Recall Management, coordinating cross-functional teams to execute containment strategies with minimal business disruption.
- Champion the adoption of Manufacturing Execution Systems (MES) and digital dashboards, CPV/OPV, and the golden tunneling of process data to streamline batch release and enhance shop-floor data integrity.
- Excellent communication skills, both verbal and written.
- Self-motivated, with a strong sense of personal responsibility.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Oversee complex cleaning validation and stratification sampling for OSD and nasal products to ensure all protocols meet 21 CFR 211 and ICH guidelines.
- Ensure drug product integrity throughout the manufacture, storage, and distribution chain by aligning site logistics with global GxP standards.
Section Head – IPQA at FTO-2
Dr. Reddy's
03.2020 - 02.2024
- Responsible for Handling and management of OOS/OOT/Deviation, CAPA and Change Controls
- Generation of CoC and approval of CoA and submission of same to QP.
- Supporting and ensuring required batch documentation to QP and Customers for batch release process to fulfil the requirements of Annex. 16.
- Responsible for handling of Risk assessments and evaluation of mitigation plans.
- Responsible for GMP compliance at production/Packing areas.
- Ensuring compliance of In-process quality checks and sampling of manufactured and packed products.
- Oversee the cleaning validation program at site for existing machine and new machine, approval of cleaning validation matrix/policies.
- Handling of returned goods of the product and conduct assessment for disposition.
- One point contact for Europe- QPs and facilitating weekly calls with QPs and Quality team of Europe/UK/Customer to supporting by means of document on time and trouble shooting of quality.
- Review and approval process validation (PPQ) protocols, technical/stratified sampling approach and reports.
- Review and approval of Work-instructions and SOP’s in Quality and Operations.
Assistant Manager (Quality Assurance-QMS) at FTO-2
Dr. Reddy's
01.2018 - 03.2020
- Responsible for OOS (Out of Specification) Management system, conducting investigation for product failures, identifying the potential root causes and implementation of adequate CAPA and ensuring effectiveness of the identified CAPAs.
- Review and Closure of Incidents, Out of trend results and Market compliant investigations.
- Change control management and CAPA tracking.
- Ensuring compliance to policies and procedures each system wise across the plant, on paper vs. practice, adherence to guidelines and recent observations across pharmaceutical industry.
- Ensuring compliance and timely closure of observations arising out of audits and relevant CAPA's.
- Responsible for preparation/compilation of Quality Metrics, plant score card followed by conducting the site Quality Management review meetings with site leadership team and tracking of the action items.
Junior Manager (Analytical Quality Assurance) at FTO-2
Dr. Reddy's
08.2014 - 12.2017
Analyst (Quality controls & Stability) at FTO-2
Dr. Reddy's
06.2010 - 08.2014
- Expertise in handling of analysis such as Assay, Related substances and other physical parameters.
- Maintaining all the relevant records and logbooks of instruments.
- Responsible for maintaining GLP, 5S and cGMP in the Laboratory.
- Handling of Agilent HPLC, Water’s HPLC (with PDA, MWD, VWD, RI detectors) and Gas chromatography with EMPOWER software.
- Handling of analytical instruments such as UV-Visible spectroscopy, KF Auto-titrator, Dissolution apparatus, Potentiometer, etc.
Education
Master of Science - Organic Chemistry
Andhra University
Visakhapatnam, India07-2010
Bachelor of Science - Mathematics, Physics, Chemistry
AMAL College, Andhra University
Visakhapatnam, India04-2007
Skills
Quality system regulation compliance
cGMP adherence in operations
Investigations for deviations/Batch failures
Change management process
Site Transfers/New Product Management
Method Transfer/Validation/Execution
Operational Excellence
Gap analysis expertise
Batch release management
Accomplishments
- Successfully handled simplification projects through a statistical based approach-such as reduced testing/Skip testing, reduction of OOS which enhanced the overall quality system.
- Certified green-belt practitioner of Lean-six sigma principles and completed most valued projects in last three years.
- Proficient and well versed with the approach of DMAIC and DMADV and have implemented various simplification, improvement, and digital initiatives through this approach. Most significant projects are Optimization of IPQC checks, Reduction in TAT of batch release, Elimination of in-process testing of blend samples, Sampling process of EU/UK testing samples at manufacturing country etc.
- I was part of core team member for Establishment of QMS system in Cambridge-UK and ensure the smooth transition of Quality systems from Beverley to Cambridge UK.
- A 3-day workshop was conducted to Uzbekistan Regulatory Inspectors on current industry practices and compliance enhancement.
- Successfully managed digital projects such as CoC digitization and IPQA dashboard etc.
- Effectively carried out my responsibilities to get first GMP certificate to plant from Russian Authority across Indian Pharmaceutical formulation units.
Certification
Lean Six-Sigma Green belt certified
Timeline
Road to Leadership an Internal Leadership Programme.
10-2025
Lean Six-Sigma Green belt certified
09-2025
Site QA Head at FTO SEZ Process Unit-01
Dr. Reddy's Laboratories Ltd.
03.2024 - Current
Section Head – IPQA at FTO-2
Dr. Reddy's
03.2020 - 02.2024
Assistant Manager (Quality Assurance-QMS) at FTO-2
Dr. Reddy's
01.2018 - 03.2020
Junior Manager (Analytical Quality Assurance) at FTO-2
Dr. Reddy's
08.2014 - 12.2017
Analyst (Quality controls & Stability) at FTO-2
Dr. Reddy's
06.2010 - 08.2014
Master of Science - Organic Chemistry
Andhra University
Bachelor of Science - Mathematics, Physics, Chemistry
AMAL College, Andhra University
TRAININGS
- Gained exposure and skills to work in the technical environments by actively attending trainings on:
- Train the trainer
- Effective Auditing skills
- Effective Investigation methodologies
- Lean-sigma process and green belt training
- Leading as People Manger
- Change Management
- AI for Everyone
PROFILE SUMMARY
A strategic and results-driven professional with 15+ years of comprehensive experience in Quality Assurance and Quality Control within the pharmaceutical industry. Currently serving as Site QA Head at Dr. Reddy’s Laboratories, with a proven track record in leading high-stakes manufacturing operations and site remediation. Expert in successfully managing complex regulatory landscapes, having navigated inspections from the USFDA (2 successful inspections), MHRA (UK), German Authority, Health Canada, and Romanian Authority with zero critical observations.
Key strengths include:
Operational Excellence: Certified Lean Six Sigma Green Belt with expertise in implementing DMAIC/DMADV methodologies
Production Remediation: Deep experience in identifying compliance gaps and designing robust remediation plans to ensure seamless manufacturing continuity.
Technical Leadership: Extensive background in OSD and Nasal formulations, overseeing complex cleaning validation, process validation (PPQ), and technical life cycle management in accordance with ICH and 21 CFR 211 guidelines.
Digital Transformation: Pioneer in Industry 4.0 initiatives, including the implementation of Manufacturing Execution Systems (MES), CoC digitization, CPV dash board, and real-time IPQA dashboards to enhance shop-floor data integrity.
Regulatory & QMS Expertise: Proficient in managing critical Quality Management Systems such as Change Control, OOS/OOT investigations, and Risk Management (FMEA).
Recognized with the Chairman Excellence Award (2023 & 2026) for leading the Best Quality Team and Best Manufacturing site and consistently maintaining A+ performance ratings for over 15 years.
Awards
- Best workplace award in Quality circle across FTO’s in 2014
- Best CFT-Award from Central Stability Department in 2015.
- Best Employee award in 2016 from hands of Global Quality Head
- Won excellence enabling award at site
- Chairman Excellence Award for Best Quality Team for the year 2023, 2026
- A+ and A ratings with a grade factor above 1.1 consistently for the past 15 years.
- Won various spot prizes for being recognized as an individual contributor and key performer.