Nrusimhadri Karthik
Senior Associate, Quality Assurance – International Affiliates Global Supply Quality | International Distribution Quality
Hyderabad
Summary
Dynamic professional seeking an environment that fosters growth and innovation, leveraging extensive experience and creative problem-solving skills to drive impactful results. Committed to utilizing knowledge and insights to contribute to the continuous development and enrichment of the industry. Eager to embrace challenges that promote both personal and organizational success, ensuring optimal potential is achieved in every endeavor.
Overview
12
12
years of professional experience
2
2
Certifications
Work History
Sr.Associate -QA International Affiliates
AMGEN INDIA LIMITED
05.2025 - Current
- Assessed and approved minor and major deviations for commercial and clinical products across global regions.
- Reviewed temperature excursions and distribution complaints, including tag alerts, for global shipments.
- Managed product complaint intake, investigation, closure, audits, report preparation, and filing.
- Supported batch disposition activities through detailed review and responsibility management.
- Prepared Smartsheet dashboards, KPI reports, newsletters, and management review presentations using Power BI.
- Coordinated with global regions and cross-functional teams, while supporting onboarding and teamwork for timely project completion.
Assistant Manager –QA QMS & Batch releases
ANTHEA PHARMA PRIVATE LIMITED
12.2024 - Current
- Reviewed executed BPCRs, master documents, change controls, micro/FP reports, and batch records for correctness and final batch release.
- Prepared and reviewed process validation and cleaning validation protocols, reports, summaries, and client submission documents.
- Managed APQR, CPV, CPK analysis, process verification, KPI reporting, and trending using tools like Minitab.
- Supported GMP documentation, quality systems, SOPs, specifications, STPs, and external supplier quality management.
- Investigated deviations, complaints, returned goods, and quality events through root cause analysis and corrective actions.
- Coordinated with clients and internal teams to support manufacturing, validation, documentation, customer satisfaction, and daily operations.
Sr. Executive –QA -QMS
BIOLOGICAL E LIMITED
06.2021 - 12.2024
- Reviewed BPCRs, master documents, change controls, micro/FP reports, stability protocols, and annual stability calendars for accuracy and data organization.
- Managed deviations, OOS, OOE, OOT, complaints, CAPA, change controls, and effectiveness checks for quality compliance.
- Prepared and reviewed APQR schedules, cleaning validation, media fill, transport validation protocols, reports, and CCTV footage.
- Performed IPQA activities including line clearance, in-process checks, sampling, reconciliation, batch calculations, and documentation.
- Verified QC analytical data, COAs, quality agreements, policies, water sampling trends, and validation report compilation.
- Supported client communication, customer satisfaction, and quality systems using TrackWise, LIMS, DMS, and SAP.
Executive - QA
GLAND PHARMA LTD
01.2016 - 06.2021
- Prepared process validation protocols and reports, including batch manufacturing steps and improvement suggestions.
- Reviewed change controls, deviations, OOS, OOT, batch failures, and product quality impact assessments.
- Investigated incidents and deviations, performed root cause analysis, and supported timely closure of quality events.
- Prepared and analyzed APQR, extracted data, and compiled manufacturing, deviation, complaint, and change control information.
- Audited executed BPCRs, master documents, and change controls to ensure accuracy and support timely batch release.
- Managed final batch release, transport validation studies, client coordination, and customer satisfaction improvements.
Sr. Production Asst (Fill finish & Sterility management)
SHANTHA BIOTECHNICS PVT.LTD
01.2014 - 01.2016
- Performed environmental monitoring, including viable and non-viable evaluations.
- Supported aseptic process simulation studies and facility qualification activities.
- Coordinated autoclave load preparation, manufacturing support, and area sanitation tasks.
- Prepared, filtered, and managed disinfectants for daily cleaning and sanitization.
- Conducted filter integrity testing using Sartocheck Plus and ensured filter efficiency.
- Maintained classified area conditions, GMP documentation, and packing material availability for filling activities.
Education
Master of Science - Biotechnology
Bangalore University
Bangalore, Karnataka 04.2001 -
Bachelor of Science - Biotechnology
Osmania University, Gayathri College of Sciences
Hyderabad, Telangana 04.2001 -
Associate of Science - Biology, Physics & Chemistry
Board of Intermediate, Gayathri College of Sciences
Hyderabad, Telangana 04.2001 -
High School Diploma -
St. Anthony's High School
Adoni, Kurnool, Andhra Pradesh 04.2001 -
Skills
- Softwares Used :SAP, TRACK WISE, LIMS, LMS & DMS & MINITAB, BIOCONNECT, ATOMIC-SALESFORCE, CTET,COLD STREAM, BTRS,AI-CI 20,POWER BI ( CERTIFIED MICROSOFT ANALYST) , CHAT GPT, COPILOT
- MS Office tools : MS Word, MS Excel, MS PowerPoint and Internet Applications
- Team leadership
- Performance monitoring
- Team supervision
- Data analytics
Certification
CERTIFIED MICROSOFT POWER BI DATA ANALYST
Timeline
CERTIFIED MICROSOFT POWER BI DATA ANALYST
05-2026
Sr.Associate -QA International Affiliates
AMGEN INDIA LIMITED
05.2025 - Current
Assistant Manager –QA QMS & Batch releases
ANTHEA PHARMA PRIVATE LIMITED
12.2024 - Current
Sr. Executive –QA -QMS
BIOLOGICAL E LIMITED
06.2021 - 12.2024
POST GRADUATE DIPLOMA IN COMPUTER APPLICATION
01-2018
Executive - QA
GLAND PHARMA LTD
01.2016 - 06.2021
Sr. Production Asst (Fill finish & Sterility management)
SHANTHA BIOTECHNICS PVT.LTD
01.2014 - 01.2016
Master of Science - Biotechnology
Bangalore University
04.2001 -
Bachelor of Science - Biotechnology
Osmania University, Gayathri College of Sciences
04.2001 -
Associate of Science - Biology, Physics & Chemistry
Board of Intermediate, Gayathri College of Sciences
04.2001 -
High School Diploma -
St. Anthony's High School
04.2001 -