Kirti Bhardwaj
Secunderabad
Summary
Results-driven Quality Professional with over 12 years of experience in Quality Management Systems and compliance within the pharmaceutical and biopharmaceutical sectors. Proven expertise in developing and implementing quality control processes that enhance productivity and ensure regulatory adherence. Skilled in molecular biology, biologics, microbiology, and OSD formulations, with a strong track record of successful audits and effective communication with auditors. Committed to leveraging extensive knowledge in equipment validation and laboratory setup to drive operational excellence.
Overview
12
12
years of professional experience
Work History
Assistant Manager (Biopharma Department)
Vimta Labs Ltd.
Secunderabad
05.2022 - Current
- Conducted comprehensive investigations of QMS events such as incidents, deviations, OOS, and OOT.
- Conducted qualification and validations in compliance with GAMP5.
- Acted as SME during regulatory and customer audits, ensuring compliance standards are met.
- Produced detailed audit response documentation showcasing adherence to compliance requirements.
- Administered laboratory operations following GLP and cGMP standards.
- Collaborated closely with interdepartmental staff to address diverse laboratory needs, fostering seamless communication and coordination to meet multiple requirements effectively
- Developed and revised standard operating procedures.
- Conducted training sessions for multiple site teams on procedures.
- Conducted thorough assessments of in-vitro cell-based studies.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Performed risk assessment activities for computer systems.
Assistant Manager
Delta Biopharma, Pvt. ltd.
Naidupeta
10.2020 - 04.2022
- Led the holistic execution of a greenfield project, managing everything from procuring instruments to validating QC and Microbiology labs.
- Developed and maintained critical laboratory documentation including SOPs, STPs, GTPs and various related records.
- Ensured all analyses of raw materials and final products met established regulatory and quality criteria.
- Oversaw stability chamber management and conducted stability sample analysis to assess product shelf-life and performance
- Effectively managed the Quality Management System, including handling Deviations, Incidents, Out of Specification/Out of Trend investigations, and Change Controls
- Optimized laboratory processes to boost operational efficiency and uphold data accuracy.
- Organized training sessions for new hires to familiarize them with the workplace environment.
- Coordinated with other departments to ensure smooth flow of operations.
- Collaborated with management on developing strategic plans for achieving business goals.
- Interviewed prospective employees and provided input to HR on hiring decisions.
- Delegated work to staff, setting priorities and goals.
Executive
Hetero labs ltd.
Jeedimetla
03.2018 - 10.2020
- I began my journey with the responsibility of calibrating critical laboratory instruments such as HPLC, dissolution apparatus, UV-Vis spectrophotometer, and FTIR, along with the management of reference standards (USP, EP, WS, etc.).
- Progressed to handling advanced responsibilities, including the review of audit trails for all computerized instruments to ensure data integrity and compliance.
- Effectively managed QMS activities, including deviations, incidents, out of specification/out of trend, investigations, and change controls.
- Actively involved in the qualification of instruments (IQ, OQ, PQ), technical document review, and software validation to ensure system compliance.
- Ensured effective implementation and management of Good Laboratory Practices (GLP) within the laboratory.
- Participated in method transfer and method validation, including protocol preparation and data review to ensure accuracy and reliability.
- SOP Development: Developed and reviewed SOPs to maintain consistency and compliance with laboratory operations.
- Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
Executive
Jiaan Biotech
Pithampur
06.2017 - 02.2018
- Executed Sterility Testing, Microbial Limit Testing (MLT), and aseptic processing.
- Monitored environmental conditions via AAS and PAS to uphold required standards.
- Effectively managed investigations, including deviations, OOS/OOT results, and incident handling
- Managed and tracked Change Control procedures ensuring continuous laboratory compliance.
- Generated, modified, and scrutinized vital documentation like SOPs and STPs.
- Guaranteed documentation compliance with cGMP and regulatory standards.
Sr. Researcher
Sonic Biochem extraction limited
Pithampur
09.2012 - 11.2016
- Utilized RT-PCR techniques for conducting GMO and Non-GMO tests, maintaining regulatory compliance.
- Created economical strategies to evaluate biochemical products, enhancing lab efficiency and utilizing resources effectively.
- Established and validated a new RT-PCR laboratory following strict standards.
- Conducted microbiological tests, such as MLT, GPT, and BET.
- Performed Environmental Monitoring to maintain aseptic conditions in laboratory and production areas.
- Qualified and commissioned lab spaces tailored to molecular and microbiology needs.
Education
MSc. - Biotechnology
Loyola Academy Degree And PG College
Secunderabad03.2012
BSc.B.Ed. - CBZ
Regional Institute of Education
Bhopal, MP03.2010
B.Ed. -
Regional Institute of Education
Bhopal, MP03.2010
12th - CBZ
Sri Chaitanya Kalasala
Secunderabad, TG03.2006
10th - Science
Kendriya Vidyalaya Hakimpet
Secunderabad, TG03.2004
Skills
- Quality Management Systems Expertise
- Equipment qualification, CSV, and software validation
- SME for regulatory audits
- Development of procedural documents
- Project management and strategic planning
- Interpersonal communication
- Continuous Improvement
- Adaptability and positive attitude
- Leadership and analytical problem solving
- Time management
- Versatile learning abilities
Personal Information
- Date of Birth: 02/15/89
- Marital Status: Single
- Address : Flat No. 302, Sri Sai Meadows, Risala Bazar, Bolarum, Secunderabad, Telangana,500010
Core competency
- Investigation of OOT, OOS, Incidents/ Deviations, LIR along with Documentation, Risk assessment and CAPA.
- Audit SME : USFDA, UK MHRA, TGA Australia, WHO Geneva, ISO, EMA etc.
- Expertise in SOP's preparation and review.
- Equipment Qualifications: HPLC, Multimode microplate reader, CDS, Spectrofluorometer, MALS, BSC, CE, CO2 incubators, KF titrators, Melting point apparatus, Dissolution, Colorimeter, polarimeter, FTIR, Luminex, FTIR, Capillary electrophoresis, Dissolution, RTPCR etc.
- Cleanroom Area Qualification
- Performing Microbiological Analysis like BET, MLT, Sterility test, RT-PCR etc.
Languages
Hindi
First Language
English
Proficient (C2)
C2
Accomplishments
- Hold NCC 'C-certificate' and performed presented state in national TSC camp.
- Served as NCC head of college.
Timeline
Assistant Manager (Biopharma Department)
Vimta Labs Ltd.
05.2022 - Current
Assistant Manager
Delta Biopharma, Pvt. ltd.
10.2020 - 04.2022
Executive
Hetero labs ltd.
03.2018 - 10.2020
Executive
Jiaan Biotech
06.2017 - 02.2018
Sr. Researcher
Sonic Biochem extraction limited
09.2012 - 11.2016
MSc. - Biotechnology
Loyola Academy Degree And PG College
BSc.B.Ed. - CBZ
Regional Institute of Education
B.Ed. -
Regional Institute of Education
12th - CBZ
Sri Chaitanya Kalasala
10th - Science
Kendriya Vidyalaya Hakimpet
Similar Profiles
Dr Ravi KacchigereDr Ravi Kacchigere
Head - Strategic Partnership and Techno-commercial at Vimta Labs LimitedHead - Strategic Partnership and Techno-commercial at Vimta Labs Limited
Harikesh JanmanchiHarikesh Janmanchi
Assistant Manager at VIMTA Labs LtdAssistant Manager at VIMTA Labs Ltd
Sachin PatilSachin Patil
• Group Leader at VIMTA LAB LTD.• Group Leader at VIMTA LAB LTD.