NIRANJAN DODDA
Quality Assurance
Hyderabad
Summary
Experienced Quality Assurance professional with 11+ years of expertise in pharmaceuticals and vaccine manufacturing. Proven success in ensuring product quality and compliance with regulatory standards. Specialized master's degree in Pharmaceutical Analysis & QA.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
Work History
Assistant Manager QA-SYST & COMPLIANCE
Biological E Limited- Biologic's (Vaccines)
08.2021 - Current
- Currently working as QMS specialist in vaccine manufacturing facility
- Review and approval of site investigations, change controls, CAPA and Effectiveness checks related to Measles rubella, Pneumococcal Conjugate vaccine, nOPV2, LPV and Td vaccine
- Conducting market complaint investigation and preparation of final report
- Responding to complainant & closure of complaint
- Trending of product Complaints
- To evaluate all the complaints and to prepare the quality investigation report in support with applicable cross functional departments
- Conducting quality contact activities for deviations, change controls, CAPA and EC in Track Wise
- Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
- Participating in new customer projects (Takeda's Dengue vaccine) and handling of QMS actions for new product introduction.
- Handling of external audits and audit responses (FDA & WHO)
- Experienced in Gap Assessment against policy and regulatory requirements
- Tracking the effective implementation of corrective and preventive action (CAPA) and conducting effectiveness checks
- Well versed with TRACKWISE QMS tool for conducting workflows of Deviations, CAPA, Effectiveness check, Change control and vendor management
- Worked for Covid-19 Vaccine project (Janssen Pharmaceuticals)
- Acquired proficiency in review with QP (M/S Janssen JNJ-Leiden) and daily review with External Quality M/S Janssen for closure of deviations
- Coordinating and handling of vendor management activities in TrackWise
Sr. Executive (E4) – Quality Assurance
Aurobindo Pharma Ltd (Injectable)-FDA Regulated
04.2017 - 08.2021
- Carried out investigations, CAPA identification, CAPA implementation and review of Change control
- Participated and co ordinated with plant RA team for responding regulatory queries on CRL from FDA with respect to sterility and visual inspection
- Participated in investigation of market complaints of lyophilized drug product
- Evaluating market complaint samples of lyophilized product
- Accomplished GAP assessments from regulatory guidance and mitigation of the GAPs
- Collaborated with QP team for investigation of packing and distribution related defects
- Carried out the Periodic review of SOPs
- Annual Product Quality Review
- PQ of LIMS
- Prepared GAP assessments for Site SOPS against the corporate quality policies which are related to leak detection in containers, visual inspector's qualification and particulate and physical defect control lifecycle management (comprehensive GAP assessment)
Executive-MQA
Pfizer HealthCare India PVT.LTD- FDA Regulated
03.2015 - 03.2017
- Carried out the review of technical specifications, batch manufacturing record, validation protocols and validation reports
- Conducted manufacturing Quality activities for sterile drug products
- Participated in manufacturing investigations and conducted effectiveness check of CAPA
- Conducted assessment of particulate matter visual inspection procedure in response to other site market complaint related to particulate matter
- Hands on experience in quality operations and supported for batch release
- Executed AQL for batch release
- Carried out recipe management and user access management as an administrator for computerized systems/Automated equipment's
- Reviewed Process Instruction (PI) Sheets in SAP for batch release and Quality notifications
- Carried out review of BPR and ECN (electronic change number) for release of process orders in SAP
- Coordinated with investigation team for manufacturing deviations
In Process Quality Assurance
GLAND PHARMA LTD- FDA, MHRA, ANVISA Regulated
04.2013 - 03.2015
- Hands on experience in QA operations of compounding and filling of injectable drugs
- Had experience in Line Clearance and BPR review
- Supervised environmental monitoring of filling area
- Conducted Sampling of intermediates, bulk solution and finished product during compounding, filtration, filling and terminal sterilization of drug product
- Handled process Validation and Submission batches
- Carried out In-process sampling and in-process control
- In process QA activities at different stages of processing (Dispensing, Manufacturing, Sterilization, Filtration, Filling, Sealing, Lyophilization, External Vial Washing and Visual Inspection)
- Monitored and executed Media fill validations
Education
Master of Pharmacy - Pharmaceutical Analysis & QA
Nandha College of Pharmacy
Erode, TN 09.2010 - 12.2012
Bachelor of Pharmacy -
Vikas College of Pharmacy
03.2006 - 03.2010
Skills
E2E Deviation management
Regulatory Audit management
Self-inspection/Internal audits
Regulatory Requirements and Compliance
TrackWise
Quality Review
Risk Assessment-FMEA
Investigations
Root Cause Analysis
Change Management
Regulatoryinspections
- USFDA, MHRA
- ANVISA,INFARMED
- EMA, WHO, CDSCO
Timeline
Assistant Manager QA-SYST & COMPLIANCE
Biological E Limited- Biologic's (Vaccines)
08.2021 - Current
Sr. Executive (E4) – Quality Assurance
Aurobindo Pharma Ltd (Injectable)-FDA Regulated
04.2017 - 08.2021
Executive-MQA
Pfizer HealthCare India PVT.LTD- FDA Regulated
03.2015 - 03.2017
In Process Quality Assurance
GLAND PHARMA LTD- FDA, MHRA, ANVISA Regulated
04.2013 - 03.2015
Master of Pharmacy - Pharmaceutical Analysis & QA
Nandha College of Pharmacy
09.2010 - 12.2012
Bachelor of Pharmacy -
Vikas College of Pharmacy
03.2006 - 03.2010
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