21 CFR PART 820, PART 11, ISO 13485, 14971, 11607 and cGMP, cGLP, cGCP.
CHEMCAD, Aspen HYSYS, WebStatistica, Trackwise, MS Office, Data Analysis
RM Plan, RM Report, IQ, OQ, PQ, TMV, WI and SOP's
CAPA, DFMEA, PFMEA, Fish bone, FTA, 5-Why
GC, HPLC, Autoclaves, Ovens, Incubators, Mass Spectrophotometer, Lyophilizers and Lab Instruments.
Simulated a mixture of gas stream such that pure component is separated.
Developed a process such that VOC emission from the tank is condensed for further use.
Super critical fluid.
Literature search on super critical fluid and C6-C8 alcohols.
Developed an experiment to create C6-C8 alcohols using super critical fluid, to get maximum conversion
Worked on Ethanol plant using PRO II and Hysys.
I did heat and material balances by drawing flow sheet and simulating in PRO II.
Calculated the number of recycle loop iterations that are necessary for the simulation to converge.
01/2013 to 02/2014
Chemical Engineer/ProcessSun Pharmaceuticals Pvt. Ltd － New Delhi, India
Extensive experience working as Process/Quality Engineer with in-depth knowledge and strong base in New Product Development, Manufacturing, Packaging, Process Validation, Test Method Validation and Equipment Qualification.
Experience includes conducting utilities validation, commissioning, qualification, laboratory equipment validation.
Hands-on experience on Lab instrument, Equipment and software such as Autoclaves, Lyophilizer, Tanks, Cold rooms, Freezers, Refrigerators, Incubators, HVAC.
Extensive Experience in reviewing Standard Operating Procedures (SOP), IQ, OQ, PQ, Validation Master Plan (VMP) and Validation Summary Reports (VSP).
Industrial experience and Good understanding of FDA's 21 CFR Parts 11, 50, 56, 58, 210, 211, 312, 314 and 820; ICH - GCP Guidelines and ISO 14971 and 13485.
Good experience in grading suppliers, developing supplier matrix and preparing Supplier Corrective Action Reports (SCAR).
Good working knowledge of FDA 21 CFR Part 11: Electronic Signatures, Electronic Records, Closed/Open System and Audit Trails.
Reviewed, approved and developed Standard Operating Procedures (SOPs), Validation Master Plan (VMPs), URS-FRS, Test Plan, Test Scripts and VSR.
Well versed in Document Change Control Techniques and methodologies.
Experience in Data Migration, Periodic Review, GAP Analysis, Risk analysis, CAPAs and Remediation Process.
Excellent Team player to work in conjunction with other testers, developers and other team members in validation and testing complex scenarios and projects and in the maintenance of Quality Standards in Projects.
Strong analytical, administrative and problem-solving skills.
Excellent written, communication & interpersonal and Project Management skills.
Quick learner and fast grasping of new concepts and Independent worker.
Six sigma green belt certified.
02/2012 to 12/2012
Chemical Engineer/ProcessCIPET Central Institute of Plastics Enginering and Technology Uttar Pradesh
Reviewed the Validation Plan, User Requirements and Regulatory and Risk assessment.
Developed Validation Protocols (IQ, OQ, PQ) for lab instruments.
Reviewed and Traced Vendors Installation qualification (IQ), Operational Qualification (OQ) and Performance Verification (PV) Protocols.
Superintended overall process through SCADA (supervisory control and data acquisition) process control.
Traced User Requirements in Trace Matrix Document during the entire validation process.
Involved in developing SOPs for the validation protocols and revised the SOPs for lab instrument handling.
Involved in executing the test protocols and writing Validation Summary Report.
Responsible for writing qualification Protocols(IQ/OQ/PQ) and execute qualification for process equipment such as CIP/SIP skid, washers, Autoclaves, ovens.
Participated in weekly CAPA review meetings, managed and issued weekly CAPA status reports and ensured CAPA's were closed on time.
Reviewed and revised meeting for PFMEA, product inspection plan and feature verification plan.
Responsible for qualifying sterilizer and depyrogenation ovens using Kaye validator.
Reviewed engineering documents for various systems - URS, FAT, PFDs, P&IDs, SOOs, Batch records etc.
Authored IQ, OQ, PQ, FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) for equipment using in the production equipment.
Assures that all new or existing equipment, instruments, utilities and process equipment are validated in accordance with requirements outlined in approved validation master plan requirements, approved validation test protocols, applicable policies and procedures.
Working closely with supplier quality engineer, R & D, manufacturing to qualify new supplier, move of an existing supplier to a new facility and qualifying new components from an existing supplier.
Inspected incoming raw materials for compliance with the ISO standards and FDA regulations.
Complying with the standards EN ISO 13485, EN ISO 14971, 21 CFR 820.30.
Evaluate existing equipment and new equipment installation against established regulations/guidelines compliance.
03/2011 to 12/2011
Chemical Engineer/ProcessDr. Reddy's Laboratories － Hyderabad, India
Wrote, reviewed and approved all design control risk management documents such as plans, hazard analysis, design and process FMEA's, and reports.
Generated, Reviewed and executed Validation and Equipment Validation protocols for Reddy's Labs.
Prepared and executed IQ, OQ and PQ of major equipment.
Involved in preparation of Test plan, Test Scenarios based on requirement, functional specification documents.
Acquired proper shutdown of equipment's for cleaning with safety work permits (confined space, work at height, hot work, cold work.).
Performed PPAP, APQP, First Article Inspection (FAIR) and incoming inspections.
Have authored laboratory testing following the company standards, designated work instructions, and ISO Forms for laboratory equipments such as autoclaves, lyophilizers, depyrogenation tunnels, etc.
Recorded the final approved data into appropriate data collection ports and updating the same within the internal databases.
Responsible for maintaining quality system regulations Part 820 and regulatory standards ISO 13485/14971.
Experienced n statistical data analysis using Minitab (Gage R&R, ANOVA studies), DMAIC and DMADV Studies.
Supplier quality - Audits, Corrective actions and improvement projects executed with suppliers.
Support the Supplier Quality Engineer with the Supplier Corrective Action Request (SCAR) and supplier process.
Developed and executed validation guidelines for GCP, GLP and GDP.
Performed manual testing involving different types of testing like positive testing, Negative testing, regression testing, system testing and user acceptance testing.
Executed Test Cases manually to check GUI and functional features, compared and analyzed actual results and reported all deviations to the appropriate individuals for resolution.
Used Quality Center to design test plan, test scripts and reported defects.
Education and Training
MS of science: Chemical EngineeringLamar University － Beaumont, TX, USAChemical Engineering
21 CFR Part 11, administrative, automation, interpersonal, Data Analysis, data collection, Data Migration, databases, Drafting, Engineer, equipment installation, fast, FAT, Factory Acceptance Testing, features, filling, Forms, functional, GC, GCP, GMP, GLP, GUI, HPLC, HVAC, IDs, Inspection, IQ, ISO, laboratory equipment, laboratory testing, manufacturing process, materials, meetings, MS Office, 2000, Minitab, New Product Development, oil, OQ, Packaging, policies, PQ, problem-solving skills, process control, processes, process equipment, Project Management, Project Plans, Protocols, Quality, Quick learner, Requirement, Risk analysis, Risk assessment, risk management, safety, SAT, Site Acceptance Testing, SCADA, supervisory control and data acquisition, Scripts, Six sigma, SOP, specification, Team player, utilities, Validation, water treatment, Excellent written