SATISH CHANDRA GUPT
Ghaziabad
Summary
Accomplished QA Manager with a proven track record at Skylimit Research Pvt. Ltd., adept in ISO 9001:2015-QMS auditing and leadership. Spearheaded quality assurance programs, ensuring regulatory compliance and enhancing study management consistency. Excelled in team management and stakeholder engagement, driving significant improvements in quality systems and processes.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Manager-QA
Skylimit Research Pvt. Ltd.
Noida
05.2024 - Current
- Implement a fully integrated quality assurance programme and provide leadership throughout the organization in order to assure regulatory compliance
- Review and approve procedures (SOPs) in compliance with established guidelines and regulatory requirements
- Contribute on project teams that assure quality standards are not met and will be responsible for assuring facilities, equipment and processes are properly validated
- Efficiently partner with head of departments for purpose of identifying non-compliance and quality issue
- Assess audit findings from internal and external quality audits and provide periodic assessment on root causes and compliance feedback with future follow-up to head of department and Senior Management
- Facilitate audits by Sponsors / Clients and Inspections by Regulatory Authorities
- Implementation of safety management system requirements at work places along with maintenance of zero injury & and fire incident
- Define effective quality system/process to ensure effective CAPA and avoid recurrence of deviations
- Ongoing review of global and practices for maintenance Identify and /or leads improvements efforts to enhance the consistency of study management activities (those internal and external) throughout the clinical study relative to current processes, regulatory guidelines and / or quality (including SOPs, ICH, GCP, FDA, DCGI etc.)
Deputy Manager-QA
Texas Biolabs Pvt. Ltd.
Noida
04.2023 - 05.2024
- Company Overview: (A Teena Labs Group Hyderabad, Telangana)
- Implement a fully integrated quality assurance programme and provide leadership throughout the organization in order to assure regulatory compliance
- Review and approve procedures (SOPs) in compliance with established guidelines and regulatory requirements
- Contribute on project teams that assure quality standards are not met and will be responsible for assuring facilities, equipment and processes are properly validated
- Efficiently partner with head of departments for purpose of identifying non-compliance and quality issue
- Assess audit findings from internal and external quality audits and provide periodic assessment on root causes and compliance feedback with future follow-up to head of department and Senior Management
- Facilitate audits by Sponsors / Clients and Inspections by Regulatory Authorities
- Implementation of safety management system requirements at work places along with maintenance of zero injury & and fire incident
- Define effective quality system/process to ensure effective CAPA and avoid recurrence of deviations
- Ongoing review of global and practices for maintenance Identify and /or leads improvements efforts to enhance the consistency of study management activities (those internal and external) throughout the clinical study relative to current processes, regulatory guidelines and / or quality (including SOPs, ICH, GCP, FDA, DCGI etc.)
- (A Teena Labs Group Hyderabad, Telangana)
Research Scientist (Assistant Manager)
Jubilant Generics Ltd.
Noida
07.2007 - 03.2023
- Company Overview: (Formerly Known as Jubilant Life Sciences Noida, U.P.)
- Steering quality control & assurance of APIs, drugs, & bioanalytical data
- Coordinating with cross-functional teams for bio studies initiation, adverse drug events (ADE) during dosing, project initiation, and on-time release of Clinical Study Report (CSR)
- Managing regulatory audits, client audits, internal system audits, facility audit, system audits, safety audits, client audits, sponsors audits, vendor audits
- Developing & ensuring adherence to the SOPs, guidelines for preparation & review of Method Development, Validation, and Transfer; monitoring quality systems and standards to maintain data integrity
- Managing change control & deviation, validating excel sheet, cleaning validation
- Assisting the project leaders in conducting bio-analysis and in maintaining the bio-analytical laboratory in conformance to Good Laboratory Practice (GLP) guidelines
- Supporting project leaders in data analysis and compilation of reports
- Heading multi-disciplinary team members to ensure efficiency in Method development and Validation
- Steering the analysis of process, samples, to ensure quality initiatives at every stage
- Formulating internal reports and other reports requested by the management related to the achievements and supervising new development plans, renewing and developing in-house group effort
- Planning day-to-day activities and resolving technical problems for timely completion of objectives; implementing new methods/ systems for the management and project deliverability
- Communicating experimental plans with alignment to strategic objectives; following up for execution and summary to management and partners
- (Formerly Known as Jubilant Life Sciences Noida, U.P.)
Research Associate
Jubilant Generics Ltd.
Noida
07.2007 - 06.2014
- Company Overview: (Formerly Known as Jubilant Life Sciences Noida, U.P.)
- (Formerly Known as Jubilant Life Sciences Noida, U.P.)
Education
Master of Science - Biochemistry
V.B.S. Purvanchal University
Jaunpur, UP01.2005
Bachelor of Science - Zoology, Chemistry
D.D.U. Gorakhpur University
Gorakhpur, UP01.2000
Skills
- ISO 9001:2015-QMS Auditor
- Quality Assurance
- Quality Control
- Audit Handling
- Vendor Management
- Bio-Analytical Method Development
- Validation
- Bio studies data review
- Clinical Audit
- Data review
- Laboratory Management
- SAP
- Eurotherm Software
- EDMS Software
- Watson LIMS software
- GLP Activities
- SOPs Development
- Equipment Management
- CAPA Review
- Calibration
- Analysis
- Testing
- Inspection
- Incident Investigation
- Stakeholder Management
- Team Management
- People Management
- Reporting
- Documentation
- Team Building
- Leadership
Certification
- ISO 9001:2015 Quality Management System (QMS) Certificate.
- 1+ Years training in Clinsys Clinical Research Ltd.: Analysis of chemical formulation by LC-MS/MS.
- Project Training on Clinical Biochemistry in Moti Lal Nehru Medical College, Allahabad.
- Training on GLP, GCP.
- Training on World Courier for Shipment and handling of Biological Samples | Vendor Training.
- Various training on Instruments and lab related activities.
Personal Information
Date of Birth: 01/10/80
Languages
- English
- Hindi
Notable Accomplishments
- Conferred with various awards & accolades across the career span.
- Successfully faced varied audits such as US-FDA, EMA (Europe), NPRA (Malaysia), INFARMED (Portugal), ANVISA (Brazil), CDSCO (India), CAP (United States), NABL (India), OECD GLP (India & Netherlands) and other international regulatory bodies.
- 13 times direct handling of USFDA audit (Onsite, Surprise & Virtual).
Location Preference
Delhi-NCR, India
Timeline
Manager-QA
Skylimit Research Pvt. Ltd.
05.2024 - Current
Deputy Manager-QA
Texas Biolabs Pvt. Ltd.
04.2023 - 05.2024
Research Scientist (Assistant Manager)
Jubilant Generics Ltd.
07.2007 - 03.2023
Research Associate
Jubilant Generics Ltd.
07.2007 - 06.2014
Master of Science - Biochemistry
V.B.S. Purvanchal University
Bachelor of Science - Zoology, Chemistry
D.D.U. Gorakhpur University
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