Quality Assurance Management

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Anuj Patel

***** ******** ***** *******, ** **617 224-***-**** ****.*****@*******.***

LinkedIn: www.linkedin.com/in/anuj-patel-h1m9a811

Work Authorization: Authorized to work in The United State of America without sponsorship. Summary:

• Dynamic and results-oriented Quality Specialist professional with over 10+ years of experience in the life science industry under the quality assurance segment. Recognized for driving proactive initiatives, ensuring compliance with industry regulations and delivering measurable results within timelines in regulated environments.

• Diligent, ambitious and target-oriented Quality Assurance Specialist proficient at monitoring quality issues, reviewing change control, OOT, Risk Assessment and maintaining standards at different organizations while designing quality regulations.

• Expert in quality management systems, compliance and deviation management.

• Work with a result-driven mindset to deliver the needs of stakeholders and sustain company standards.

• Excellent verbal and written communication skills.

• Able to deliver top-notch client approach and support while working effectively with members of a large team environment.

• Adept at driving projects to successful completion through strong communication and collaboration. Core Competencies:

• GMP, GDP, GLP, GXP.

• EU-GMP

• Product Recall

• Deviation Management

• Quality Management

• APQR/CPV

• Risk Management

• Validation /Qualification

• Change Control

• AQL

• Internal Audit

• Market Complaint

• Cleaning Validation

• Batch Release

• CAPA, OOS/OOT

• Internal Audit

• Time management

• Attention to Detail

• Communication

• Problem-solving Leadership

• ISO14155, 20916

• ISO 9001, 14001, 13485

• ICH Q7, Q8, Q9, Q10

• ISO 13485, 14644, 15378

• ICH Q7, Q09, Q10,

• 21 CFR 610

• ISO14155, 20916

• FDA 21 CFR 210,211, 820

• ISO 22716,

Technical skills:

Validation and Qualification: Sterilization validation Smoke Study Isolator Qualification Process Validation Cleaning Validation SIP Validation HVAC Qualification Temperature Mapping Facility Qualification Water System Qualification Utility Qualification Facility design review URS DQ FAT IQ OQ PQ RQ SOP Validation Protocol writing Report writing P &ID review Layout review Regulatory compliance QA and QMS: Audit Readiness Quality Assurance Aseptic Quality Assurance Quality Risk Management Documentation Management Change Control Deviation Incident CAPA Root Cause Investigation Data Integrity Good Documentation Practices Data Analysis Statistics Data Visualization Tools: MS Office Trackwise Documentum Validator Kaye AVS Data logger Tableau Software Master Control 2

Regulatory knowledge: cGMP 21 CFR Parts 210 and 211 21 CFR Part 11 ISPE PDA GAMP 5 EU GMP Guidance for Industry ISO

Soft skills: Critical Thinking Problem-Solving Technical Writing Quick Learner Continuous Quality Improvement

Transformational Leadership

Education and Certification:

• Master of Science (International Business and Management), University of Dundee, Dundee 2020

• Master of Pharmacy, Gujarat Technology University, Ahmedabad 2013

• Bachelor of Pharmacy, R. G. H. S. University, Bengaluru 2010 Certifications:

• Project Management

• Digital Marketing

• Leadership

Work Experience:

Manager Validation & Qualification Jan-2025

KriGen Pharmaceutical LLC, 800 Edwardbrother Dr, Lillington, North Carolina, 27546.

• Preparation, review and Approval of VMP, SMF, QM, Validation Protocols/Reports, SOPs and their effective implementation Qualification of HVAC, Autoclave, Dehydrogenation Tunnel, Manufacturing Vessels/ Skid, Compressed Air & Nitrogen Distribution System, Water System, Pure Steam, LAFs, DPBs.

• Qualification of Walk-In-Coolers, Stability Chambers, Deep Freezers and Hot Air Oven.

• Preparation and review of Area Qualification and Facility Qualifications protocols and Execution of Qualification.

• Planning, monitoring and execution of calibration and qualification of various instruments as per planned schedule.

• Development & Implementation of life cycle methodology as per CSVMP for Automated Manufacturing Process Control, Laboratory Computerized System & Enterprise applications at organizational level as per 21 CFR Part 11, EU Annexure 11 & GAMP 5.

• Preparation, Review and Approval of Computerized System Validation documentation/deliverables & SOPs.

• Manage Quality Management System (QMS) elements like Change Controls, Deviations, CAPAs, Root Cause Analysis, Risk Assessment, Out of Specification and Self inspection.

• Perform Remediation, Gap Analysis, Risk Assessment & Periodic Review of Computerized System.

• User Management in Laboratory Systems, Computerized System Inventory Management, Spreadsheet Validation, Audit & Compliance.

• Review Data Governance – Data Integrity Risk Assessment (DG-DIRA) document.

• Audit Laboratory, Manufacturing and IT applications & computerized systems.

• Review and Approval of facility, area and Equipment /Instrument Risk Assessment.

• Ensure 21 CFR Part 11/EU Annex 11 compliance of Computerized Systems.

• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory guidelines from agencies such as the FDA, EMA, or other relevant authorities.

• Conduct internal and external audits to assess compliance with quality systems, manufacturing processes, and regulatory requirements.

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• Ensure that batch records and other documents related to the production process meet all quality and compliance criteria.

• Maintain detailed documentation related to quality processes, testing results, non-conformances, and corrective actions.

• Prepare and review quality-related reports for management, regulatory bodies, and other stakeholders, ensuring that all findings are communicated clearly and effectively.

• Investigate and document any deviations from established quality standards, implementing Corrective and Preventive Actions (CAPA) as necessary.

• Ensure that all products are released according to established quality and regulatory standards. Review the results of quality tests and ensure the product is safe for use or sale.

• Review and investigate customer complaints related to product quality, supporting the investigation process to identify root causes and corrective actions.

• Evaluate and qualify suppliers for raw materials, components, and services, ensuring they meet the necessary quality standards.

• Conduct periodic reviews and audits of suppliers to assess their continued compliance with quality expectations and standards.

• Collaborate with cross-functional teams to improve manufacturing processes, quality systems, and operational efficiency. • Use tools like Lean or Six Sigma methodologies to reduce waste, optimize processes, and improve quality metrics.

• Provide training and guidance to new and existing employees on quality standards and regulatory compliance.

• Continuously monitor and update knowledge of pharmaceutical regulations, guidelines, and industry best practices.

• Assist in the preparation of regulatory documents and filings, ensuring that all necessary quality data is included.

• Communicate with regulatory bodies during inspections, audits, or investigations, responding to questions and providing documentation as needed.

• Evaluate and mitigate potential quality risks in the manufacturing process, ensuring that risks to product quality and patient safety are minimized.

• Perform risk assessments related to quality systems, processes, and product batches, implementing appropriate controls to address potential issues.

• Ensure the proper storage, handling, and labeling of raw materials, in-process materials, and finished goods to prevent contamination and ensure traceability.

• Help maintain the QMS, ensuring that documents, specifications, and standard operating procedures

(SOPs) are up to-date and compliant with regulations.

• To provide necessary support and input to R & D during product/process development, technology transfer and new product launches.

Quality Specialist-III May -2024 to Dec 2024

Kashiv Biosciences, 3440 South Dearborn Street #300 Chicago, IL

• Facilitate the implementation of a robust Quality Operations Management system, ultimately leading to improved product quality.

• Supervise rigorous testing procedures to ensure the integrity and reliability of medical device products, safeguarding against potential defects, recalls and adverse events.

• Ensure meticulous documentation and records for Corrective and Preventive Actions (CAPA), complaints and Non-Conformance Reports (NCR), ensuring strict adherence to industry protocols and guidelines while actively championing continuous improvement endeavors.

• Efficiently investigate GMP events, initiate deviations, summarize and close deviations. 4

• Provide written responses/resolutions to customers regarding product quality complaints or product inquiries.

• Support and collaborate with multiple departments to ensure timely documentation, perform a root cause analysis and execute the closer of deviations, change controls, OOS/OOT.

• Lead periodic Global QMS meetings, coordinate with Global QMS contacts and manage the Global QMS Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs

• Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents

• Perform QA presence & process confirmation on shop floor

• Participate in project teams as a quality resource

• Support, review & approve investigations & root-cause analysis

• Participate in process confirmations & Go Look Sees

• Evaluate trend & report data for QMRs & APR reports

• Consults with clients on production and documentation.

• Assists with development of SOPs or other quality documents.

• Maintains accurate files and records.

• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.

• Complies with company polices and SOPs.

• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

• Facilitate implementation of corrective actions for processes and for the Quality Management team.

• Prepare reports for processes, findings, timeliness of communications, next steps and effectiveness checks.

• Assist cross-functional teams in working together to solve problems by finding out what’s causing a problem and using methods like asking “5 why” questions, Ishikawa / PDCA / 5-D / 8-D amongst other processes and following step-by-step improvement plans.

• Coordinate internal training and record keeping related to corrective actions and preventative actions

[CAPA]/ measures.

• Assist in maintaining and developing GCS Quality Management Systems (QMS) in compliance with industry quality standards-ISO 9001.

• Provide written responses/resolutions to customers regarding product recalls.

• Audit Exposure: During the FDA and NVISA audits, the SME for Quality Management Systems is responsible for addressing deviations, conducting thorough investigations and implementing CAPA (Corrective and Preventive Actions) to ensure compliance and improve processes. Quality Specialist-I May 2023 to May 2024

Fresenius-Kabi, 2020 N Ruby St, Melrose Park, IL 60160

• Promote constant quality improvements by being present on the shop floor. Act skillfully and honestly to make sure quality standards are met and the right procedures are followed.

• Performs quality review and approval of documents, data, protocols, and/or reports.

• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).

• Performs visual inspection of parenteral product (requires qualification).

• Performs internal quality audits and/or inspections.

• Supports client audits and inspections, and regulatory inspections.

• Maintains quality databases.

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• Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness.

• Assists with quality improvement initiatives as needed.

• Consults with clients on production and documentation.

• Assists with development of SOPs or other quality documents.

• Maintains accurate files and records.

• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.

• Complies with company polices and SOPs.

• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

• Escalate isolated and systemic issues to site management, including proposed CAPAs.

• MQA shop-floor activities must cover the entire production and support processes which depending upon the plants business operations will include but not be limited to: bulk solution preparation, weighing and dispensing verification.

• Component preparation, identification and verification, monitoring of in-process controls.

• Oversight of filling/lyophilization activities (including completion of Aseptic Gowning Qualification).

• Performance of visual inspection (AQL) and packaging oversight.

• Warehouse/Storage requirement adherence.

• Monitoring of facilities and utilities per required parameters.

• QA key contact for shop-floor employees.

• On the floor QA contact to escalate issues and provide real-time documentation requirement/troubleshooting analysis.

• Participate in 5S activities.

• Utilize TrackWise, SAP Master Control and Veeva for report creation, SOP writing, investigation writing, raise/log deviation, CAPA and change control.

• Shop-floor documentation review of MBR logbooks for GMP and procedural compliance.

• Support quality, compliance and continuous improvement projects.

• Special oversight activities based on case-by-case demand to include but not limited to media fills repackaging, reworking, validation/investigation study activities, investigation, root cause analysis, annual product review, initiation of changes through change management and other duties as assigned.

• Deviation: technical writer who investigates, summarizes and closing of the deviation.

• Assist with initiation and completion of change controls, including the development of a change plan, completion of impact assessment and management of change.

• During the FDA audits, the SME for Quality Management Systems is responsible for addressing deviations, conducting thorough investigations, and implementing CAPA (Corrective and Preventive Actions) to ensure compliance and improve processes

Quality Specialist- Team lead May 2016 to May 2023 Alidac Pharmaceutical Limited, Plot No.1a, Pharmez, Sarkhej Bavla N.h. No. 8a, Ahmedabad, Gujarat 382213

• Supplier Quality Management (Vendor Management), including auditing, preparation of protocol, preparing and review of approved supplier list.

• As part of each investigation, gather information from all necessary internal and external sources to evaluate the root cause of the deviation and impact on all manufactured products, as well as the risk to future operations.

• Prepares and analyzes manufacturing and laboratory historical data and uses root-cause analysis tools to determine root cause(s) and apply effective CAPA to mitigate future occurrences. 6

• Ensures compliance with relevant Standard Operating Procedures (SOPs); while gathering, analyzing and applying information from internal and external sources to perform a risk assessment of the impact each process deviation has on the product, process and patient health and safety.

• Ensures that deadlines are met and closely monitors the need for extensions to maintain compliance to site and industry standards.

• Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems and properly assess risk/impact.

• Updates SOPs and/or Manufacturing Batch Records (MBRs), as required, based on CAPA and continuous improvement needs.

• Assists with initiation and completion of change controls, including the development of a change plan, completion of impact assessment and management of change.

• Prepare review and approve of media fill protocol, monitoring media fill intervention and aseptic behavior.

• Prepare an Annual Product Quality Review (APQR) report for each commercial product as per a predefined timeline.

• Maintained ISO quality management system, by implementing the quality assurance procedures to meet corporate quality policies.

• Provide written responses/resolutions to customers regarding product quality complaints or product inquiries.

• Assisted in supplier qualification, review, and management processes as necessary as well as maintenance of the

• Approved Supplier List (ASL) (Vendor Qualification/ management)

• Planned aseptic products manufacturing with strict implementation of GMP and work structures based on quality reports.

• Scheduled and executed batch reviews and managed deviation through batch disposition in accordance with product release dates and maintained delivery within deadlines.

• Identified GAPs in operations and improved through Quality Assurance reports.

• Support customer inquiries and complaints procedures with the support of Quality Leads.

• Reviewed and approved suppliers/service providers including supporting with audits of critical suppliers where required.

• Operating on time GMP achievement and reporting GMP and product quality issues Quality Management team.

• Assisted in the implementation of an ‘Audit Ready’ compliant site which is always ready for USFDA, MHRA, and TGA, corporate, internal, or 3rd party audit. Surveying audit reports to mark quality lapse causes and report them.

• Provide written responses/resolutions to customers regarding product quality complaints or product inquiries.

• Reviewed Standard operating procedure, BMR, BPR, SMF, and Quality Manual and accordingly planned batch releases.

• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis and closer of, Deviation, Change control, OOS/OOT, and CAPA.

• Managed change control, deviations, CAPA, and market complaints and trained recruits to handle the same.

• Guaranteed standard maintenance through Facility Checklist, Batch Auditing Checklist of BMR &BPR, Internal and external audit-related assessment, and compliance with cGMP manufacturing & packing area.

• Performs quality review and approval of documents, data, protocols, and/or reports.

• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).

• Performs visual inspection of parenteral product (requires qualification).

• Performs internal quality audits and/or inspections.

• Supports client audits and inspections, and regulatory inspections.

• Maintains quality databases.

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• Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness.

• Assists with quality improvement initiatives as needed.

• Consults with clients on production and documentation.

• Assists with development of SOPs or other quality documents.

• Maintains accurate files and records.

• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.

• Complies with company polices and SOPs.

• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

• Audit Exposure: During the FDA, NVISA, German FDA, CDSCO, and Customer audits (USA & Europe) audits, the SME for Quality Management Systems is responsible for addressing deviations, conducting thorough investigations, and implementing CAPA (Corrective and Preventive Actions) to ensure compliance and improve processes.

Quality Specialist May 2013 to April 2016

Intas Pharmaceutical Limited, 496/1/A & B, Sarkhej-Bavla, Highway, Ahmedabad, Gujarat, India - 382210

• Performs quality review and approval of documents, data, protocols, and/or reports.

• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).

• Performs visual inspection of parenteral product (requires qualification).

• Performs internal quality audits and/or inspections.

• Supports client audits and inspections, and regulatory inspections.

• Maintains quality databases.

• Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness.

• Assists with quality improvement initiatives as needed.

• Consults with clients on production and documentation.

• Assists with development of SOPs or other quality documents.

• Maintains accurate files and records.

• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.

• Complies with company polices and SOPs.

• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Contact this candidate