D S Keerthi Bharadwaj
Hyderabad
Summary
Adaptable Quality professional with a 11+years background in implementing and developing improvement processes through collaboration with cross-functional teams. First-rate computer, analysis, and research skills. Specialties include achieving set targets, generating new strategies and maintaining accurate records. Valuable team player with progressive experience and proven significant, successful contribution in quality management, process improvement and systems in well renowned organizations. Looking for a company which will challenge problem solving skills and allow to continue to develop knowledge and potential.
Overview
1
1
Certification
Work History
Quality Specialist, Corporate Quality Systems
Indian Immunologicals Limited
- Responsible to provide GMP, EHS & QMS trainings to new joined employees.
- Provide on job trainings to employees by taking training needs.
- Enhanced team performance through regular training sessions and knowledge sharing, resulting in an increase in overall efficiency.
- Prepare annual self-inspection schedules and conduct internal audits as per the schedules.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Follow up with the auditee team and implement the action plans against the observations through proper QMS tool.
- Harmonization of procedures across all sites of the organization to meet product quality standards.
- Identify gaps in the SOP's , implement the procedures as per the regulatory guidelines and provide guidance's/ procedures for site level SOP's.
- Preparation of summary reports of annual performance review of inspections and trends for APQR data.
- Data summarization for monthly and half yearly Management Review meetings.
Assistant Manager, Quality Systems
Biological E Limited, Hyderabad
- Quality Management Systems – QC Compliance.
- Assist HOD with planning schedules and delegating assignments to meet coverage and service demands.
- Document, track and report deviations and Change controls.
- Involved in Investigation of incidents, deviations, OOS & Market complaints to evaluate root cause.
- Review of change controls and implementation of CAPA's.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Preparation/execution/reviewing/approving method development, validation activities, reports.
- Review of Process Validation Protocols, PV batch records &reports.
- Well versed with Track wise and LIMS management systems.
- Testing and releasing of Tetanus and Antisera in-process and bulk samples in LIMS.
- Reporting, evaluating, approval of analytical data using various laboratory IT systems, LIMS.
- Sample receipt, distribution, tracking of results, reviewing reports and archival.
- Preparing lot summary protocols and releasing batch COA's as per market requirement.'
- GMP lot release and stability testings of biologics.
- Planning stability studies to assign product shelf life , preparation of stability protocols, summary reports in LIMS for regulatory submission.
- Maintenance of reference standards from NIBSC/CRL kasauli /WHO for preparation of IHRS standards used in in-process and final bulk testings.
- Qualification of water systems.
- Handling and troubleshooting of Total Organic Carbon Analyzer.
- Trending of data and preparation of quarterly summary reports.
- Worked as training Coordinator by Conducting on job trainings, external trainings and preparation of Job profiles/descriptions of employees.
- Preparation of Employee training matrix and maintenance of Analyst qualification and re-qualification Schedules.
- Lead team member in the audits like CDSCO, WHO, ANVISA etc.
- Conducting Internal audits for compliance in production,QC, QA, House-keeping, Safety and On-line documentation.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
Technical supervisor
Bio-analytics, Zydus Cadila Healthcare Ltd
- Assist with method development and validation of analytical assays
- Sterility testing of bulk and lot samples by direct inoculation and membrane filtration.
- Water sampling, testing and preparation of trends.
- Receive, submit, distribute, track and coordinate samples for testing.
- Log and maintain all reference standards used for testing (Both microbial and chemical tests).
- Implemented rigorous quality control measures to ensure all products met or exceeded industry standards before release to customers.
- Documentation and maintaining of laboratory books.
- Writing and reviewing of standard operating procedures.
Education
Post graduate diploma - Operations Management
Prin. L.N. Welingkar Institute of Management & Research
Mumbai, MH04.2019
Bachelor of Engineering - Bio-Technology
Aarupadi Veedu Institute of Technology
Chennai03.2010
Intermediate - Bi. P.c
State Board of Intermediate Education, Kakatiya Junior College
Hyderabad03.2005
S.S.C -
Board of Secondary Education, St. Augustine English Medium High School
Anantapur03.2003
Skills
- Quality processes/QMS implementation
- Audit and compliance
- Risk assessment/Investigations support
- In-process/Lot release of biologics
- Lab IT systems,LIMS,vision pro,Trackwise etc.
- Stability studies/extended stability studies
- Data reporting/review/approval/archival
- Employee training
- TOC Analyzer calibration/trouble shooting
- Familiarity with quality standards
- Problem-solving abilities
- Knowledge of quality systems
- Teamwork
Core Competencies
- Quality Management System activities.
- Audit and compliance
- Identify training needs, annual training schedules, Employee training as training coordinator role.
- Handling deviations, Change controls and Corrective & preventive actions in Track wise application.
- Review of SOP's, Specifications, preparation and execution of protocols.
- Expertise in operation and trouble shooting of laboratory information management system (LIMS).
- Release of Batch COA's and lot summary protocols· QC Compliance with respect to cGMP and cGLP regulatory requirements.
- Ability to transfer knowledge and educate GMPs.
Products Handled
- Pentavalent vaccines
- Anti-snake venom serum
- Anti-snake venom Central Africa-6 & African 10
- Diphtheria anti-toxin
- Tetanus anti-toxin
- Rabies vaccine
Certification
- Certified Six Sigma from IIT Kharagpur with Elite performance
- Completed master program on lean six Sigma expert from simplilearn
Accomplishments
- Successfully completed a 3-day training program from BIO Monitoring filtration school on - “comprehensive course on pharma Microbiology” conducted by Merck Millipore, Bangalore
Languages
English
Proficient
C2
Hindi
Advanced
C1
Tamil
Intermediate
B1
Telugu
Bilingual or Proficient (C2)
Declaration
I hereby declare that all the information provided by me in this application is correct and factual to the best of my knowledge and belief.
Date:
Place:
Signature
D. S. Keerthi Bharadwaj)
Timeline
Quality Specialist, Corporate Quality Systems
Indian Immunologicals Limited
Assistant Manager, Quality Systems
Biological E Limited, Hyderabad
Technical supervisor
Bio-analytics, Zydus Cadila Healthcare Ltd
Post graduate diploma - Operations Management
Prin. L.N. Welingkar Institute of Management & Research
Bachelor of Engineering - Bio-Technology
Aarupadi Veedu Institute of Technology
Intermediate - Bi. P.c
State Board of Intermediate Education, Kakatiya Junior College
S.S.C -
Board of Secondary Education, St. Augustine English Medium High School
- Certified Six Sigma from IIT Kharagpur with Elite performance
- Completed master program on lean six Sigma expert from simplilearn
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