Quality Assurance Qa Lead
Resume:
Hayward, CA *****
********@*****.***
JITENDRA KUMAR
PROFILE
Over 28 years of cGMP/GCP experience in pharmaceutical industry in clinical and commercial biologics manufacturing, Computerized Validation, small molecules and Quality Assurance, Project Management, eQMS, ICH Guidelines, EU and FDA Guidelines. Experienced on Quality Management systems, ISO9001, CGMP, with focus on analytical equipment, computerized system validation and Data Integrity
EXPERIENCE
Research Compliance Analyst (Contract Position)
University of California San Francisco (UCSF)
November 2024 - Present
QA Lead for Human Islet Cellular Transplantation Facility (HICTF) for UCSF GMP Manufacturing.
Perform quality assurance activities for the UCSF Investigational Cellular Therapy Group, UCSF HICTF and GMP Facility, and the Pediatric Cellular Therapy Laboratory.
QA Lead for Laboratories that support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies.
Support the group is on first-in-human phase 1 clinical trials.
Work with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in the biopharmaceutical industry that has collaborations or manufacturing activities ongoing at UCSF.
Work in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
Investigational Cellular Therapy material and raw material release.
Drug Product (DP) and Drug Substance (DS) material release.
QA Lead for internal audit of GMP Manufacturing, Quality Management Systems (training, document management, Investigations, Change Controls and CAPA) and other Quality
Approve Chain of Custody documents for Investigational Cellular Therapy material shipments.
Quality Systems and Compliance Sr. Specialist
Contract Position (Remote), Moderna, MA
October 2023-March 2024
Support Lot Release for Final (Clinical) Product by reviewing and approving supporting documentation for Lot Disposition.
Assist in development and training of internal Clinical Quality and Process Validation (PV) processes.
Review and update end to end validation documentation for IRMS, Trackwise (CAPA, CCM) to ensure Data Integrity and compliance with company policies and procedures.
Support internal and external PV and GCP audits, Clinical QA (CQA) audits, schedules, and war room activities.
Reviewed and updated Validation deliverables that are required by SDLC policy and FDA regulation.
Author and Review of documents of GxP system/ applications as per SOPs and regulatory guidelines (e.g., GAMP5, 21CFR Part 11, EU annexure 11).
Support the oversight of the performance of QMS by leading/contributing to Management review meetings and monitoring the state of control through metrics and key performance indicators for Commercial DS organization.
Lead quality issue escalations /recalls and ensure adequate corrective and preventive actions are put in place.
Ensure that all Process Validation (PV) and GCP activities are completed and recorded properly, on time, and in accordance with Standard Operating, Procedures (SOP), Good Documentation Practices (GDP), cGMP, and FDA requirements.
Perform audits in support of the internal audit program and support customer and regulatory inspections at CMOs for the DS organization.
Implemented the Software Life Cycle documents meet compliance standards per FDA regulations 21 CFR Part 11.
Prepared Validation Protocol, deviation log, signature identification sheet etc., to describe the validation activities performed during the test phase of SDLC.
Support pharmacovigilance (PV) activities by collecting safety data and product complaints.
Support management in overall Quality Management System (QMS), quality manual, policies and procedures for the DS organization Support pharmacovigilance (PV) activities by collecting safety data and product complaints and ensure continuous improvement (while keeping it updated with emerging and changing regulations), guidance documents and current industry best practices and expectations.
Developed 21 CFR Part 11 validation procedures for clinical trial and development laboratory raw materials dispensing system
Own and drive Deviations, Investigations and CAPAs which are related to Quality systems and Quality compliance aspects.
Support quality-related information requests raised by partners/customers and Health Authorities
Validated the Operational and Performance Qualification for LIMS.
Provide cross-functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and release, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations, as applicable.
Support Annual Product Review report generation and approval
Support Continual Improvement initiatives, programs, and projects.
Support domestic and international Regulatory Authority Inspections and Notified Body Audits.
Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.
Maintains and evaluates weekly KPIs, Regulatory Submissions, Regulator Information Management (RIM), 3rd Party Logistics (3PLS).
Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic quality systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.
Support and lead programs strengthening the general compliance of eQMS such as data integrity, Regulatory Compliance, Quality Risk management, Training Management and continuous improvement for the rapidly expanding GXP environment.
Manager Development and Commercial Quality Assurance
Gilead Sciences, Foster City, CA 94404
Nov 2017-Nov 2022
Program Management and Team Lead for Project Portfolio Management (PPM).
Responsible for developing, tracking and monthly and quarterly contract manufacturing KPIs for Clinical products and Process Validation activities.
Train internal and external staff/contractors on GCP and PV processes.
Approve final release of label APIs, Clinical Drug Products and bulk materials.
Review and approve off-labeled drug-products and placebos for clinical use.
Lead for Continuous Improvement Program Team for the department. Track progress using SmartSheet and train multiple functional areas on using SmartSheet.
Validated systems are Labware LIMS v6 and v8, Valgenesis and Veeva Vault.
Revision of Computer System Master Validation Plan based on GAMP V and the new CSA Methodology.
Converted Instructor Lead Training (ILT) to Web-Based Training (WBT) using Captivate. Added this training to LMS (Veeva)
Train functional groups on Veeva and overall eQMS.
Migrated eQMS from Trackwise to Veeva.
Review and approve life cycle documentation, Change Controls, Validation Plans, URS, etc.
Drafted and executed Qualification and Requalification protocols for the analytical Equipment such as HPLC, GC, UV- Visible spectrometer, TOC Analyzer, ICPMS.
Reviewed and approved Labware 8 - OQ scripts using the Valenesis testing tool. Defects are tracked while processing testing and reported using ValGenesis.
Responsible for reviewing and approving validation documents for global LIMS implementation
Validated systems are Labware LIMS v6 and v8, Valgenesis and Veeva Vault.
Approved deliverables like Validation Plan and Validation Summary Document for each project implementation.
Reviewed and approved FS and TS for custom programs in LIMS for various business processes in accordance with Part 11 and GMP regulations.
Approve Expiration Date Extensions for Clinical products.
Approve External Event investigations for Site and Shipping Excursions using GCLP guidelines and Stability Data.
Process Management for Key Performance Indicators (KPIs) for small molecule multiple clinical and commercial products, including injectables, sterile and pre-filled syringes, and auto-injectables.
Reconcile data from multiple sources to support Monthly Core Metrics for the department.
Lead/participate in project team to streamline Clinical and Commercial processes and SOPs by reviewing existing workflows and identifying areas for improvement and supporting Periodic Reviews.
Responsible for ensuring departments project status updates are current in Quality Plan.
Work closely with CMO Managers to provide status updates to Management for all open Quality Events.
Provided CMO Oversight of EU companies under ICH and EU guidelines, including Health Canada.
Support pharmacovigilance (PV) activities by collecting safety data and product complaints.
Compile and reconcile data from multiple databases (IQS, GVault, Trackwise, GBAS, etc.) for CMO performances (CXO Risk Model Dashboard).
Support internal and external audits.
Lead document retention and archiving efforts for the department and removed backlog of over 8000 documents.
Internal audits and walk-through.
Manage clinical trial site excursions.
Project Management for the department functional teams.
Supporting Lot Releases for Canada and Ireland QA Functional areas using EU, PMDA (Japan) and TRMH (Russian) guidelines.
eQMS Computer System Validation.
Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.
Approving medical devise/combination product Validation Protocols, Technical Reports and Summary Reports.
Working knowledge of root cause analysis (RCA) methodology and testing methods (e.g Bioburden, Endotoxin, A280, HPLC/UPLC, PCR, ELISA, Bradford, Activity and Bioassays) to support QC investigations involving multiple manufacturing modalities (e.g. Gene Therapy, Biologics, Small Molecules) for Clinical and Commercial products.
Intarcia Therapeutics, Hayward, CA 94545
Sr. Manager, GMP Documentation Specialist, Validation and Compliance, Development, Technology & Engineering
Jul 2017-Nov 2017
Implement Learning Management System (LMS) . Document Management System from paper based to Veeva.
Overall administration and training on QMS
Review and approve GxP records for manufacturing function. GxP records include Production batch records, SOPs, Forms, Validation (IQ, OQ, and PQ) protocols and reports, Change Control and other GMP documentation associated with manufacturing.
Write and revise Manufacturing SOPs, master batch records, incoming and final product inspection criteria, PST protocols and reports and other GMP records associated with manufacturing operations in accordance with GMP regulations and guidance.
Conduct and write quality investigations for all non-conforming materials including product complaints including CAPA effectiveness checks.
Ensured Project Life Cycle documents meet compliance standards per FDA regulations (21 CFR Part 11, Part 210, Part 211, Part 820, GAMP5 etc.) and local applicable regulations.
Escalate quality and compliance issues to QA and Sr. Management.
Compile, track and trend production metrics i.e., Key Performance Indicators (KPIs) for batches manufactured, released, production errors, closure of deviations, CAPA.
Write periodic summary reports summarizing key production metrics and present to Sr. management.
Support manufacturing in planning, validation and other day-to-day routine production activities i.e., line clearance, in-process testing, and equipment qualification.
Established expiration dates for Manufacturing intermediates and documented in Technical Reports.
Planned, wrote and successfully executed multiple packaging and shipping validation for final products.
Authored packaging and shipping SOP for final product
Authored Validation Master Plan for labeling, packaging, and shipping of final products.
Support PAI readiness inspection and represent manufacturing during regulatory inspections and internal audits.
Manage other Production responsibilities as assigned by Management.
Assisted in Design Control of Drug/Device combination product.
Manage Clinical Trial data planning, implementation, management and create metrics.
Lead/support validation efforts and deliverables for projects requiring validation.
Create and execute validation test scripts and document test results in accordance with standards.
Project management for shipping and packaging.
Review and approve Clinical Trails data using GCLP guidelines.
eQMS Computer System Validation.
Gilead Sciences, Foster City, CA for Validant (Contract Position)
Sr. Computer System Validation Engineer Lead
Oct 2016-Jul 2017
Tracking quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, Change Requests, Audit Reports, and Product Complaints) for adherence to organizational and departmental targets.
Support implementation of Trackwise Crystal Report, Audit Trails, Dashboards by testing scripts and reviewing user requirements.
Responsible for maintaining tracking tools/databases. Responsible for sending periodic reminder notifications to leads/coordinators. Review deviations, audit results, and other quality indicators to identify potential compliance issues or trends.
Authored, reviewed, and approved the following validation deliverables - IQ/OQ Protocols, Risk Assessment, Summary Report, Change Controls Regulatory Assessment, 21 CFR Part 11 Assessment, Validation Plan, Training Plan, Issues Log, Design Review, Risk Assessment, Incident Reports, Problem Reports, Change Controls, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Trace Matrix, and Validation report.
Support management review process through development and generation of quality system metrics and trending. Prepare and present deviation trend reports. Report trends to management
Support the maintenance and improvement to quality systems processes. Discuss potential recurring / systemic issues with process
Work directly with operating entities and internal clients to ensure follow-up of quality issues.
Validated Val Genesis and label printer.
Participate in the development of training programs regarding all aspects of producing quality products.
Serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products and GxP electronic systems.
Assist compliance audits as required. Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.).
Internal audits and walkthroughs.
eQMS Validation.
Bayer Health Care, Emeryville, CA for Total Validation Services (TVS)
Senior Validation Specialist-Contract Position (Jan 2016-Sept 2016)
• Supporting Validation and Relocation activities for QC Lab
Boehringer Ingelheim, Fremont, CA for Total Validation Services (TVS)
SR. CSV Validation Engineer
Feb 2014-Oct 2015
Serve as owner for Engineering and Validation Change Controls and Deviations and CAPAs, Risk Assessments. Manage Quality Systems matrices for Engineering Department.
Developed software validation methodology that complied with six regulations and standards (FDA General Principles of Software Guidance, GAMP 5, 21 CFR Part 210/211, 21 CFR Part 11, ITIL, and Eudralex Annex 11). This new methodology ensured that software validations were performed uniformly and correctly.
Responsible for providing technical support and technical expertise to project team to facilitate resolution of system and quality issues
Responsible for preparing, executing and/or reviewing validation deliverables for the client Deliverables include start-up procedures, commissioning documents, validation protocols and reports (IQ, OQ, PQ, process validation, cleaning validation, etc.), development of reports, acceptance testing protocols, production of user requirements, specifications, standard operating procedures and other documentation required for the completion of the validation
Boehringer Ingelheim, Fremont, CA.
Computer Validation Specialist/CSV Specialist -Contract Position
Apr 2013-Feb 2014
Assist in creating end user trainings, SOP and other materials for TrackWise and SAP applications
Perform review and approval of all core and non-core batch records to ensure Good Manufacturing Practices (GMP) compliance
Perform review and approval of Validation Protocols and Summary Reports
Provided regulatory guidance regarding Computer System Validation (CSV) procedures, Part 11 and current Good Manufacturing Practice (cGMP).
Ensure timely initiation, classification, closure and effectiveness evaluation of deviations or non-conformances (NCs), and CAPAs
Perform Risk Assessments for GMP processes and equipment to endure compliance.
Represent Engineering group in cross-functional team meetings for clinical and commercial production campaign.
Lead/support validation efforts and deliverables for projects requiring validation.
Create and execute validation test scripts and document test results in accordance with standards.
Amgen Inc, Fremont, CA.
Quality Specialist II-Contract Position
Jan 2011-Apr 2013
Assist in creating end user training material, for TrackWise and SAP applications.
eQMS Computer System Validation.
Support implementation of Trackwise Crystal Report, Audit Trails, Dashboards by testing scripts and reviewing user requirements.
Perform review and approval of all core and non-core batch records to ensure Good Manufacturing Practices (GMP) compliance.
Perform review and approval of Validation Protocols and Summary Reports.
Ensure timely initiation, classification, closure and effectiveness evaluation of deviations or non-conformances (NCs), and CAPAs
Review, assess, and approve change control records.
Perform review and approval of new and/or revised Standard Operating Procedures (SOPs), and Manufacturing Procedures.
Represent QA group in cross-functional team meetings for clinical and commercial production campaigns.
Review and approve completed equipment log-books, executed Manufacturing Procedures, and Batch Records.
Approve line-clearance activities and non-routine sample requests.
Schedule QA off-shift support of Manufacturing.
Develop and maintain QMS elements e.g. document control, change control, quality records, internal audits, corrective & preventive actions
Represent QA in meetings with external clients and vendors (audits, deviations, etc).
Compile and present monthly department metrics, QMS indicators and performance and Key Performance Indicators (KPIs) to Senior Management and Functional Review Board (FRB).
Assist Senior Management with executing Continuous Improvement (CI) initiatives.
Review and approve Change Controls of process equipment and documents.
Review and approve CAPAs.
Perform weekly Manufacturing walk-throughs and audits
Support Regulatory inspections and audits.
Genentech Inc, SSF, CA 94066
Feb 1994 – Nov 2010
Multiple years’ experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility.
Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundamentals, and industry trends, Validation Lifecycle approach.
Hands-on experience working with Cell Culture and Purification equipment (CHO and E-Coli) with sound knowledge of aseptic processing and supporting technologies and Cleaning Validation in multi-product facility.
Hands-on experience working with Autoclaves, Centrifuges, automated cleaning (CIP) and Steaming (SIP) systems and Continuous Process Monitoring Systems
Continuous process improvement experience such as Operations Excellence.
Supported regulatory inspections and filings and have a good understanding of quality systems such as Quality/Change Control, Contamination Responses, Deviation/CAPA, Production Controls, Material Controls, Facilities/Equipment Controls, Six Sigma and Kaizen.
Ability to organize and manage projects, work independently or in large and small cross-functional teams, with focus on Continuous Improvement initiatives
Possess strong technical writing, project management, verbal communication, troubleshooting, and problem solving skills.
Reporting and/or software updates and revalidation to improve the overall accuracy, efficiency, and effectiveness of QMS systems (Trackwise and SAP)
Assist in creating end user trainings, SOP and other materials for Quality Management Systems
Knowledge and experience with improvements of QMS software systems (i.e. TrackWise, SAP)
Strong understanding of the current pharmaceutical industry and applicable regulations.
Experienced in quality systems, technology transfer, scale up and validation
Hands on experience and knowledge of equipment, facility, process and software validation
Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks
Hands-on experience in Clinical/R&D production in Pilot Plant and in tech transfer to clinical manufacturing for multiple products
Project Management for department
EDUCATION
MBA with Distinction, 2008 Keller Graduate School of Management, Fremont, CA.,
B.Sc, Technology Management, (Cum Laude) 2006 DeVry University, Fremont, CA
College of San Mateo, San Mateo, California
Math (Algebra, Calculus, Trigonometry), Organic and In-Organic Chemistry, Physics, Microbiology, Psychology and English
SKILLS & INTERESTS
Analytical skills and a strong technical background on antibody process development, validation (equipment, processes, computer systems)
Use of Six Sigma, Lean Manufacturing, Kaizen
Excellent written and verbal communication skills
Excellent organizational skills and ability to independently manage multiple projects/tasks based on shifting priorities
Highly proficient with various Microsoft and other computerized systems (Word, Outlook, Excel, PowerPoint, Visio, SharePoint, Veeva, Trackwise, Jira, Tableau, Master Control, Slack, Box, Bluecord and Smartsheet)
Support implementation of Trackwise Crystal Report, Audit Trails, Dashboards by testing scripts and reviewing user requirements.
Supported transition from Trackwise to Veeva Vault.
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