Sheetal Patel Email & Phone Number

Gujarat, India

Chicago, Illinois, United States

- Achieved the status of Kneat Superuser and Master Trainer within a span of 4-6 months.- Led and managed Veqtor's out-of-the-box solutions on the Kneat platform, overseeing pre-configured flows for Change Management, Risk-Based C&Q, Vendor Assessment, Management of Master System List, Logbooks, and Traceability Matrix. This included 32 document templates and 80 test case creations.- Authored 50% of the content for Veqtor's out-of-the-box solutions on the Kneat platform.-… Show more - Achieved the status of Kneat Superuser and Master Trainer within a span of 4-6 months.- Led and managed Veqtor's out-of-the-box solutions on the Kneat platform, overseeing pre-configured flows for Change Management, Risk-Based C&Q, Vendor Assessment, Management of Master System List, Logbooks, and Traceability Matrix. This included 32 document templates and 80 test case creations.- Authored 50% of the content for Veqtor's out-of-the-box solutions on the Kneat platform.- Successfully conducted testing of Veqtor's out-of-the-box solutions on the Kneat platform.- Developed workflows for Veqtor's out-of-the-box solutions on the Kneat platform.- Authored Change Management SOP and Training SOP + Video for Veqtor's out-of-the-box solutions on the Kneat platform.- Served as Kneat Subject-Matter-Expert (SME), Project Manager, C&Q SME, and Master Trainer for over 10 Kneat deployments for top-tier life science companies.- Managed dedicated resources for each Kneat deployment across multiple clients.- Acted as the architect of workflows in Kneat for clients.- Successfully led and managed Hypercare post-deployment activities for Kneat clients.- Established Kneat Services and Support pillar for Veqtor in the US leading to increase in revenue. -Established Veqtor as Kneat Platform Partner, Kneat Implementation Partner, Kneat Academy Specialist and Kneat Program Specialist.- Developed an in-house Kneat Training program for Veqtor to speed up training process and avoid high cost of training outside.- Led Kneat proof-of-concept initiatives for clients.- Created and presented Kneat Demos for Veqtor and Kneat, showcasing their features to prospective clients.- Known for delivering highly effective demos within Veqtor and Kneat.- Successfully managed parallel Kneat projects in six different time zones.- Consistently completed all projects on time and under budget.-Led creation of Kneat services marketing material for Veqtor for conferences and social media. Show less

Chicago, Illinois, United States

-Managed a group of C&Q specialists and engineers.-Oversaw Kneat C&Q projects and served as the Technical Kneat Subject-Matter-Expert (SME) for deployment and customer support.-Demonstrated exceptional communication skills in coordinating team members, clients, and project leads.-Acted as a C&Q SME, utilizing ASTM E2500 risk-based C&Q strategies, procedures, policies, and guidelines.-Established a track record of successful project management and leadership, with expertise in… Show more -Managed a group of C&Q specialists and engineers.-Oversaw Kneat C&Q projects and served as the Technical Kneat Subject-Matter-Expert (SME) for deployment and customer support.-Demonstrated exceptional communication skills in coordinating team members, clients, and project leads.-Acted as a C&Q SME, utilizing ASTM E2500 risk-based C&Q strategies, procedures, policies, and guidelines.-Established a track record of successful project management and leadership, with expertise in planning, organizing, and driving results.-Stayed informed about C&Q trends, compliance, and regulatory issues, effectively conveying and conforming systems and processes.-Took initiative and independently managed commissioning, qualification, calibration, and validation projects.-Consistently followed through on tasks and demonstrated a proactive approach.-Possessed knowledge of minimal protocol requirements and authored various life cycle documents associated with C&Q and validation.-Developed project budget proposals based on client Request for Proposals (RFP).-Provided project planning, management, execution, and follow-up.-Investigated failures and deviations as part of the quality control process.-Evaluated design and requirement specifications to ensure systems were fit-for-purpose.-Collaborated with clients in managing change control processes.-Initiated and resolved client Corrective and Preventive Actions (CAPAs).-Coordinated with contractors, suppliers, and internal stakeholders to ensure project success.-Provided ongoing progress reports to clients and VEQTOR management.-Ensured adherence to company SOPs and external regulations, maintaining accurate project documentation.-Demonstrated problem-solving skills, swiftly troubleshooting issues and implementing effective solutions. Show less

Melrose Park, Illinois, United States

-Single handedly managed Quality programs for the Expansion Project to ensure compliance with company policies, procedures, and regulatory standards.-Oversaw QA review and approval of project documents related to facilities, utilities, maintenance, and equipment.-Provided Technical Reviews and approved various project documents, including Project Validation Plan (PVP), User Requirements Specifications (URS), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Design Qualification… Show more -Single handedly managed Quality programs for the Expansion Project to ensure compliance with company policies, procedures, and regulatory standards.-Oversaw QA review and approval of project documents related to facilities, utilities, maintenance, and equipment.-Provided Technical Reviews and approved various project documents, including Project Validation Plan (PVP), User Requirements Specifications (URS), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Design Qualification (DQ), GAP assessments, cycle developments (VHP, Autoclave, CIP, SIP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), Process Performance Qualification (PPQ), Batch records, Media Fill Studies, Risk Assessments (Equipment, Process, Cross-contamination, Safety, Health, and Environment), and Standard Operating Procedures (SOPs).-Supported the expansion project team with budget and schedule-related aspects, providing technical expertise and quality oversight for cycle development, equipment and facility commissioning, qualification, and validation.-Conducted root cause analysis and implemented corrective and preventive actions (CAPA) to address any deviations or non-compliance.-Analyzed data, performed gap analyses and risk assessments, developed corrective and preventive actions, and implemented procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with regulatory requirements (e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO, etc.).-Led interactions with regulatory officials to communicate the compliance level of the facilities and equipment quality system of the expansion project under the FMD-135 program with the FDA.-Maintained quality systems metrics related to the expansion project to drive continuous improvement.-Participated in talent acquisition, retention, and technical grooming of resources to meet dynamic project staff augmentation needs. Show less

Chicago, Illinois

Due to my previous track record of working with Adello (TPI then), exceptional work ethic, dedication, professionalism and knowledge, I was specifically asked for this contract as the company trusted me to provide the right services needed to set them to product product for trials.-Led Equipment Qualification for up-stream and Down-stream equipment including: homogenizers, Bioreactors, centrifuges, Filling machines, etc.-Led the re-qualification of all temperature controlled equipment… Show more Due to my previous track record of working with Adello (TPI then), exceptional work ethic, dedication, professionalism and knowledge, I was specifically asked for this contract as the company trusted me to provide the right services needed to set them to product product for trials.-Led Equipment Qualification for up-stream and Down-stream equipment including: homogenizers, Bioreactors, centrifuges, Filling machines, etc.-Led the re-qualification of all temperature controlled equipment and rooms including: Refrigerators, Freezers, warehouses and Cryo-freezers- Led the requalificatiom of all cleanrooms -I authored all change controls, URS's, risk assessments, protocols, reports, deviations and traceability matrices for Facility and equipment including executing them myself and also assist in the execution and review of other protocols in the validation team. Show less

Illinois, United States

Kankakee, Il

• Author, Review and Execute protocols for the following to support the Quality Assurance-Validation Services team: Support Studies, Performance Qualifications, Cleaning Validation, Mixing Validation, Post Clean Hold Times, Product Intermediate Hold Time and Manufacturing Process Validation for the following equipments utilized in the manufacturing process of Intermediate (IV Precipitate) for commercial product- CSL112®:• Fractionation Tanks and Associated Transfer Lines• Buffer… Show more • Author, Review and Execute protocols for the following to support the Quality Assurance-Validation Services team: Support Studies, Performance Qualifications, Cleaning Validation, Mixing Validation, Post Clean Hold Times, Product Intermediate Hold Time and Manufacturing Process Validation for the following equipments utilized in the manufacturing process of Intermediate (IV Precipitate) for commercial product- CSL112®:• Fractionation Tanks and Associated Transfer Lines• Buffer Tanks and Associated Transfer Lines• Filter Press Performance Qualifications, Cleaning Validation, Mixing Validation, Post Clean Hold Times, Product Intermediate Hold Time and Manufacturing Process Validation for the following equipments utilized in the manufacturing process for commercial product- Berinert®:• Process Tanks and Associated Transfer Lines• Resin Columns• Parts Washer• Bag Filters and Associate Hoses.• Filter Press Commercial Fill Finish Facility Requalification. Requalification of Sterilizer Load, Vial Washer, Depyrogenation Tunnel and Pasteurizer. Warehouse Temperature Mapping. Chambers Re-Qualification: Cooler, Incubator and Freezer.  Cleaning Validation for process tanks, Columns, Transfer Lines, Filter Housings and Small Parts. Document Management using LIMS, Plateau, Trackwise, GDRS and DCMS. • Initiate and Author Change Control Requests and Discrepancies in TrackWise.• Author and Execute Post Cleaning Hold Studies.• Author and Execute Resin Hold Studies and Maximum Buffer Hold Studies.• Calculate Total Surface Area for product Contact Parts of Process Equipment for Cleaning Validation Studies. Show less

3440 S Dearborn Street, Chicago, Il 60616

• Review validation documents including URS, DQ, protocols and reports (IQ, OQ, and PQ), traceability matrices, and process validation (PPQ) to support the commissioning and qualification for the Fill and Finish manufacturing areas. Commissioning & Qualification and Validation activities to address the following disciplines: Facility  Regular Utility and Clean Utilities Equipment (Autoclave, Lyophilizer, Mixers, Washer)  Process Equipment (Automation Process… Show more • Review validation documents including URS, DQ, protocols and reports (IQ, OQ, and PQ), traceability matrices, and process validation (PPQ) to support the commissioning and qualification for the Fill and Finish manufacturing areas. Commissioning & Qualification and Validation activities to address the following disciplines: Facility  Regular Utility and Clean Utilities Equipment (Autoclave, Lyophilizer, Mixers, Washer)  Process Equipment (Automation Process Control)  Aseptic Filling Equipment (RABS, Vial and Syringe Fillers)  Inspection and Packaging  Building Management System  Process Automation  Process Validation  Cleaning Validation  Utilities (Nitrogen, Clean Compressed Air, WFI, and Clean Steam) Packaging/ Shipment Integrity Studies• Review and Approve Change Control Requests, Deviations, System Impact Assessments and Material Impact Assessments.• Review and Approve Failure Mode Effect Analysis for all critical aspects of a Commercial Fill And Finish Process.• Review and Approve SOP’s (Standard Operation Procedures), Forms and Production Batch Records required for establishing the document structure for a new Commercial Fill and Finish facility.• Lead and Manage FDA Inspections on-site by providing relevant documents as requested by the Auditors.• Review and Approve Flow Diagrams for Cleanrooms, P&ID’s for Utilities and Equipments and Clean room Classification Maps. Show less

Glendale Heights

• Undertake preventative maintenance and completing the necessary preventative maintenance documentation.• Undertake unplanned / emergency maintenance and completing the necessary maintenance work order documentation.• Support the engineering team with troubleshooting and repair of various equipment and systems.• Undertake equipment mechanical upgrades and completing the necessary equipment change control documentation.• Assist in equipment qualification, including execution… Show more • Undertake preventative maintenance and completing the necessary preventative maintenance documentation.• Undertake unplanned / emergency maintenance and completing the necessary maintenance work order documentation.• Support the engineering team with troubleshooting and repair of various equipment and systems.• Undertake equipment mechanical upgrades and completing the necessary equipment change control documentation.• Assist in equipment qualification, including execution support for IQ, OQ, PQ(s) and requalification.• Support the purchase, construction & installation of new equipment and systems.• Identify the equipment, systems and processes that do not operate efficiently and develop and implement corrective actions to improve efficiency.• Review equipment logs and identify equipment performance trends and make recommendation for improvement in equipment efficiency.• Ensure that the required spare parts / consumables are available for equipment operation, preventative maintenance and repairs.• Implement required maintenance SOPs.• Implement required preventative maintenance procedures.• Support validation of the equipment and systems.• Undertake instrument calibrations.• Catalog / manage equipment software.• Undertake equipment reliability reviews.• Make recommendations to production for the most effective use / training of operating personnel based on equipment reliability. Show less

Hoboken, Nj

o Method development and validation for the content uniformity and swabbing technique using DoE and HPLC.o Determined the right concentration of the cleaning agent the DOE feature of Minitab.o Raw material and finished product analysis.o Submission of lab reports on schedule and uploading the same on electronic management system- Mfiles.o Developed cleaning SOPs and provided training.o Prepared gantt chard for the entire project.o Prepared the facility layout… Show more o Method development and validation for the content uniformity and swabbing technique using DoE and HPLC.o Determined the right concentration of the cleaning agent the DOE feature of Minitab.o Raw material and finished product analysis.o Submission of lab reports on schedule and uploading the same on electronic management system- Mfiles.o Developed cleaning SOPs and provided training.o Prepared gantt chard for the entire project.o Prepared the facility layout using VISIO.o Assisted the process development scientist in making batch records.o Conducting statistical analysis on the test results of each batch and recording each in a logbook in a cGMP compliant manner. o Assisted Project engineer in qualifying the oven using thermocouples and Data Logger. Show less

Hoboken

o Assisted Reference and Research Services Librarians by staffing the desk and IM reference.o Handled and redirected incoming calls as needed.o Assisted faculty, students, staff, and library visitors with their reference questions.o Represented the library and Stevens with a professional and helpful manner.o Logged inquiries for statistical reporting.o Assisted librarians with library activities, workshops, and events.

Hoboken, Nj

-Update Alumni information by calling them.-Asking Alumni for donations.

Ahmedabad, India

o Assisted the manufacturing head in the tablet manufacturing supply chain.o Made batch records for each batch.o Assisted validation engineer in preparing IQ, OQ and PQ protocols and executing the same.o Performed quality testing on the finished products like- Dissolution and Disintegration, viscosity using brook filed viscometer, hardness, etc.

Gujarat, India

o Assisted Quality Engineer in reviewing the batch reports and test results.o Performed qualitative tests on final products using HPLC. o Conducted Root cause analysis of process critical parameters.o Created training SOP’s, trained professionals and prepared and managed training records.

Master Of Science, Pharmaceutical Manufacturing And Engineering, 3.5 Gpa

Activities and Societies: 1. International Society for Pharmaceutical Engineering 2. Stevens Pharmaceutical Research CenterClub 3. Women.

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, 4.0 Gpa