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
Secunderabad
03.2012
BSc.B.Ed. - CBZ
Regional Institute of Education
Bhopal, MP
03.2010
B.Ed. -
Regional Institute of Education
Bhopal, MP
03.2010
12th - CBZ
Sri Chaitanya Kalasala
Secunderabad, TG
03.2006
10th - Science
Kendriya Vidyalaya Hakimpet
Secunderabad, TG
03.2004
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.
North America Sales Manager, Business Aviation at SGS Global/ ARGUS InternationalNorth America Sales Manager, Business Aviation at SGS Global/ ARGUS International
<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC