Krina Patel
Hillsborough,NJ
Summary
Accomplished Quality Assurance professional with a proven track record, enhancing compliance and quality systems through expert management of Quality Events and robust document control. Skilled in eQMS like Trackwise and Veeva Vault, coupled with exceptional problem-solving abilities, ensures continuous improvement and regulatory adherence in fast-paced environments.
Overview
11
11
years of professional experience
Work History
Manager, Laboratory Quality and Data Integrity
Pfizer
09.2021 - Current
- Manage, and approve activities of laboratory assets to ensure compliant Asset Management.
- Author, Review, Approve of laboratory procedures(SOPs), test methods(TMs) and Quality technical documents.
- Author, Review and Approve Quality Events: Deviations, Change Controls, OOTs, Nonconformances, and Corrective and Preventive Actions.
- Assisting and guiding Lab personnel on Quality standards and processes.
- Creating and implementing a training session for personnel to ensure understanding of the Quality Management System, Quality standards and compliant operations.
- Appointed Change Control Lead to analyze impact on SDLC legacy processes and documentation.
- Plan and implement periodic laboratory inspections/walkthrough within several laboratories.
- Author, review and approve procedural, qualification and validation documents.
- Establish, manage, track, trend and deliver timely reporting of Quality Events and presentation during Quality Forums.
- Maintains a culture of quality awareness, teamwork, and cooperation within departmental groups.
- Implement, maintain, and continually assess Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.
- Lead the implementation of robust Quality Management systems Qualio and Veeva – system development, validation and integration.
- Audit and Inspection Support: Supporting internal and external audits and inspections to ensure compliance with regulatory standards by ensuring proper audit preparation, reporting and management.
- Quality risk assessment to ensure continuous improvement withing quality and compliance group.
- Cross functional collaboration with operations and lab management to ensure Quality and Compliance.
- Author, Review and approve Quality Agreements for Qualification and Monitoring of external Contract Laboratories.
- Streamlined Change Control process and successfully ensure around 100+ change controls backlog closed and approved.
Quality and Compliance Specialist
Johnson and Johnson
05.2015 - 09.2021
- Implemented robust record-keeping systems that ensured accurate documentation as per regulatory requirements.
- Served as a SME for guidance on compliance matters,
- Assisted in the preparation of regular reports detailing compliance activities.
- Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
- Batch record releases, change batch status through SAP and MARC transactions for product releases.
- Inventory control and inspection of Inbound and outbound products.
- Work within Quality Management Systems like Trackwise (ETS) for change control analysis, investigations.
- Ensure quality and compliance in receiving (incl. receiving inspection) and distributing products.
- Support internal and external Quality audits as backroom support and document processing.
- Ensure efficient distribution of clinical materials as per supply chain standards.
- Conducted thorough risk assessments to identify potential areas of non-compliance and recommended corrective actions.
- Ensure incoming products were temperature controlled and analyze temperature excursions to ensure stability and product efficacy.
- Record Clerk for QA department: Organize and manage all records and documents in an orderly manner.
- Maintained version control for all documents ia compliant document management processes.
- Provided assistance with inbound and outbound document processes and change notice creation.
- Maintained document control system and updated work instructions, procedures and associated databases.
- Facilitated timely project completion by managing the distribution of essential documentation to project team members.
- Enhanced data accuracy by performing regular audits on documentation and records within Document retention room.
- Increased efficiency with the implementation of electronic document management systems DocSpace/Veeva Vault for easy access and retrieval.
- Collaborated across departments and levels of management to gain consensus on procedural documentation submitted for periodic review/updates to ensure document compliance.
- Follow Data Integrity and Good Documentation Practices.
- Assist and regulate outside storage of records by cooperating with third party vendor (Iron Mountain).
Quality Technical Associate
Sun Pharma
11.2016 - 05.2017
- Follow GMP guidelines and adhere to Quality principles.
- Preparation of pre-validation and process validation documentation such as CCRs, MBRs, protocols, and reports.
- Oversee manufacturing process pre-validation and validation batches by cross functional collaboration.
- Maintenance and preparation of Master Batch Records.
- Maintenance and preparation of SOPs related to Manufacturing Science & Technology Group (MSTG).
- Quality reporting, investigation, and closure of events, change controls, deviations, CAPA, and incidents.
Laboratory Technologist
ITC
04.2014 - 05.2015
- Continuously improved laboratory processes through regular review and implementation of updated industry standards.
- Trained new Laboratory Technologists on best practices and standard operating procedures, ensuring consistent team performance.
- Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions.
- Provided technical guidance and training to laboratory staff.
- Prepared and examined specimens using variety of instruments, histologic and molecular diagnostic techniques.
- Perform testing of biological raw materials and finished goods per relevant SOP; release acceptable product.
- Analyzing data and tracking relevant trends. Record, evaluate, interpret, and summarize technical data.
- Maintain laboratory housekeeping and supply levels in the QC laboratory.
- Investigate and resolve non-conforming material and performance issues.
- Incoming QC inspection of raw materials and parts to ensure proper inventory management.
Education
MBA -
John Hopkins- Carey Business School
Baltimore, MD08-2026
Bachelor of Science - Biotechnology
Kean University
Union, NJ08-2013
Skills
Quality Expert Skills:
Quality Assurance, Quality Events Management within R&D, Manufacturing and Supply Chain industries
Knowledge of quality principles and regulations (FDA, ISO ALCOA, ICH, EU)
Expertise on eQMS like Trackwise, Veeve Vault, Qualio
Attention to Detail, risk assessment, root cause analysis, SDLC analysis
Technical writing, review, approval of Quality Events
Document Control, Records Management, and Document Training
Knowledge of basic statistics, data management and data integrity
Audit Management, Inspection readiness, Lab Walkthroughs, Asset management, Supply Chain Management, Document Management, Training and Records Management
New system implementation: Qualio, Veeva Vault
Core Skills:
Microsoft Office applications, Word, Excel, PowerPoint, SharePoint, and Visio
Positive work attitude that supports teamwork, Collaborative approach and continuous improvement
Ability to make pragmatic decisions by utilizing critical analytical and problem-solving abilities
Multi-tasking capabilities to meet priorities and ensure time management
Empathetic communication abilities to make social and professional relations
Drive for continuous improvement
Handle projects and ensure compliant project management activities
Expert on different GxPs standards including Documentation, Manufacturing, Distribution, Clinical and Laboratory practices
Systems
Document Management: Documentum, Veeva Vault, GDMS
Quality Management: TrackWise, Qualio
Asset Management: EAMS
Distribution/Operation System: MARC, SAP
Learning Management: Summit, Compliance Wire, P2L
Records and Information Management: SharePoint, GREATS
Timeline
Manager, Laboratory Quality and Data Integrity
Pfizer
09.2021 - Current
Quality Technical Associate
Sun Pharma
11.2016 - 05.2017
Quality and Compliance Specialist
Johnson and Johnson
05.2015 - 09.2021
Laboratory Technologist
ITC
04.2014 - 05.2015
MBA -
John Hopkins- Carey Business School
Bachelor of Science - Biotechnology
Kean University
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