Sudheer Kumar Kari
Senior Executive - Quality Control | 12 Years | Transitioning to Regulatory Affairs | SMART eCTD Certified | USFDA - WHO-GMP | M. Pharm (Pharmaceutical Analysis)
Hyderabad,Telangana
Summary
CMC Documentation Specialist organizing 5–10 CMC sections for regulated market submissions, including COAs, stability data summaries, and CTD Module 3.2.S.4 / 3.2.P.5 content. Translates QC outputs into submission-ready technical documentation with strong control over formatting, traceability, and inspection-ready records. Combines analytical method validation knowledge with eCTD preparation skills to support clean dossier assembly.
Overview
3
3
Languages
5
5
Certifications
14
14
years of professional experience
Work History
Senior Executive — Quality Control
Natco Pharma Ltd.
05.2019 - Current
- Executed analytical "Method Validation" for 12 USFDA ANDA products — zero analytical deficiency Letters or Form 483 observations raised on any validated method across all 12 products; all AMV packages accepted by Regulatory Affairs for USFDA filing without revision.
- Delivered 200+ Certificates of Analysis (COAs) and Stability Data Summaries — analytical data directly contributing to CTD Module 3.2.S.4 and 3.2.P.5 CMC sections for USFDA and WHO-GMP regulated market submissions across entire tenure.
- Reduced OOS investigation closure time by 35% — introduced a structured root cause analysis template adopted department-wide, eliminating OOS investigation backlogs and improving regulatory inspection readiness across the QC department.
- Successfully supported 2 USFDA Pre-Approval Inspections (PAD as QC lead — zero critical observations raised on analytical records, data integrity, or laboratory documentation in either inspection.
- Authored 18 SOPs and 12 STPs — all documentation packages passed internal GMP audits and external WHO-GMP inspections without major findings, demonstrating sustained documentation accuracy and regulatory compliance.
- Maintained 100% ALCOA+ data integrity compliance across HPLC (Waters, Shimadzu), UPLC, and Dissolution platforms per 21 CFR Part 11 electronic records requirements — no data integrity queries raised across entire tenure.
- USFDA & WHO-GMP Approved Facility | Oral Solid Dosage Forms | injectables | ANDA Pipeline
- Senior Executive — Quality Control Natco Pharma Ltd. Ma 2019 — Present Hyderabad
Executive — Quality Control
Zenotech Laboratories Ltd.
09.2017 - 04.2019
- Completed QC release testing for 80+ commercial batches per year with 100% on-time batch disposition — supporting uninterrupted product supply to USFDA and EU regulated markets throughout 2-year tenure.
- Contributed analytical data packages for 6 ANDA submissions — stability trending reports and specification justification documents incorporated into CTD X2.P.8 sections with no data quality queries from Regulatory Affairs or agency reviewers.
- Participated in analytical method transfer for 4 products from R&D to QC — all transfer protocols completed and accepted by Regulatory Affairs without rework, enabling seamless product handover with zero analytical failures.
- Supported WHO-GMP inspection and USFDA PAI site readiness — zero critical observations raised on QC records or analytical procedures under direct responsibility during both inspections.
- Associated with Sun Pharma | USFDA & WHO-GMP Approved Facility | Oral Solid Dosage Forms | ANDA Pipeline
- Executive — Quality Control | Zenotech Laboratories Ltd. Associated with Sun Pharma Sep 2017 — Apr 2019 | Hyderabad
Analyst
Divi’s Laboratories Ltd.
01.2013 - 01.2017
- Performed routine analytical testing, method verification, and stability testing for API products in USFDA and EU regulated environment — building foundational QC analytical skills, GMP documentation discipline, and regulatory compliance awareness applied across all subsequent senior QC roles.
- Maintained analytical instrument operation, calibration records, and laboratory documentation per GMP requirements — establishing complete ALCOA+ data integrity practice that underpins all subsequent inspection-ready QC career achievements.
- API Manufacturing | USFDA & EU Regulated | Analytical Testing | GC Operations
- Analyst: Quality control Divi’s Laboratories Ltd. 2013-Se 2017 Hyderabad
Education
M. Pharm - Pharmaceutical Analysis
M.A.M. College of pharmacy
Guntur01-2016
B. Pharm - undefined
Siddhartha College of pharmacy
Guntur01-2013
Skills
CTD Module 3 CMC authoring 32S4 & 325
Stability Studies & Data Packages ICH QIA/B
USFDA and WHO-GMP Inspection Readiness
CMC documentation
Regulatory submission support
Analytical Method Validation (ICH Q2R1)
OOS Investigation & CAPA SOP/STP Authoring
21 CFR Part II ALCOA Data Integrity ILIMS
HPLC method development
Chromatography troubleshooting
Certification
Hands-On eCTD Preparation & Submission Training Program (3-Month) | Pharma Growth Hub | SMART eCTD with AI Automation | 2026-JUNE 5th
Accomplishments
- Zero analytical deficiency letters on 12 USFDA ANDA AMV packages — 100% first-pass Regulatory Affairs acceptance rate across all method validation packages managed at Natco Pharma.
- Zero critical observations across all USFDA PAI and WHO-GMP inspections participated in throughout 12-year QC career — consistent documentation accuracy and laboratory compliance record across Natco, Zenotech, and Divis.
- 200+ COAs and Stability Data Summaries authored — all forming direct CTD Module 3 CMC input with no data quality revision requests from Regulatory Affairs or agency reviewers.
- OOS investigation closure time reduced 35% at Natco — structured RCA template adopted departmentwide, measurably improving regulatory inspection readiness and investigation quality.
- 12 years across three USFDA-regulated companies (Natco Pharma, Zerotech/Sun Pharma, Divis Laboratories) — broad multi-site analytical QC expertise across OSD, injectable, and API dosage form categories applicable to CMC documentation across all CTD Module 3 sections.
Timeline
Senior Executive — Quality Control
Natco Pharma Ltd.
05.2019 - Current
Executive — Quality Control
Zenotech Laboratories Ltd.
09.2017 - 04.2019
Analyst
Divi’s Laboratories Ltd.
01.2013 - 01.2017
B. Pharm - undefined
Siddhartha College of pharmacy
M. Pharm - Pharmaceutical Analysis
M.A.M. College of pharmacy