Amit Jain Email & Phone Number

Frederick, Md, Us

Wilmington, Nc, Us

Wilmington, Nc, Us

New York, New York, Us

• Authored Installation, Operational, Performance Qualification of the 3 major filling lines (Vial Line 1, Vial Line 2, and Abboject Line) and Integrated line PQs.• Authored Project Validation plan, URS, Design Qualification, SOPs, and Summary report for the filling lines.• Authored Installation and operational qualification of the Facility and assist in OFCA IQ/OQ execution.• Converted all the design documents as per Pfizer policy and regulatory requirements.• Generated Test matrix following each URS requirement and Pfizer Quality Policy.• Reviewed ETOP, SAT, FAT, Change Controls, Automation Change Controls, Engineering Change Modification, Engineering study, Commissioning, and Validation deviation reports.• Responsible for the execution of the IQ, OQ, and PQ of the filling lines (Washer, Trayloader, Puck washer, Depyrogenation Tunnel, Filler, RABS, and Isolators).• Member of Major decision-making team, which is responsible for Qualification strategy, Commodity order, line availability, Protocol template, Risk assessment, etc.• Responsible for managing a team (2 people/ Filling Line) in order to complete the qualification work in a timely manner.• Performed Temperature mapping for the Depyrogenation Tunnel, SIP for the filling lines as part of the OQ.• Performed GMP criticality Alarm Assessment for the filling line equipment, Historian Points Criticality Tag assessment.• Performed ERES assessment for the Filling lines.• Conducted field inspections including piping and equipment walk-downs, operational startup and troubleshooting.• Initiated change controls to determine the impact of changes to the facility, utilities, and equipment, as applicable.

Hatboro, Pennsylvania, Us

Gaithersburg, Maryland, Us

Authored and executed Installation and Operational Qualifications for Incubators, Freezers, Refrigerators, LN2 freezer, Multitron, Mixingtank, Wave bioreactors and Bio-Welders and centrifuges.Performed Performance qualification for Bioreactors, Mixing tanks and Bio-weldersPerformed GAP assessment for the upstream and downstream equipmentAssist vendor in IOQ for the GE AKTA Chromatography system.

Gaithersburg, Maryland, Us

• Performed SIP sanitization and SIP sterilization for buffer hold tanks, formulation tanks using Kaye validator• Developed and executed PQ protocol for the Bioreactors , Autoclave, LN2freezer, Incubators, Freezer and WFI water• Create a validation master plan for “Device Development” laboratory• Performed steam Quality test for autoclave• Developed and executed IOQ protocol for the BMS panel, Labx software, Air handler unit, HVAC, Kaye validator, Kaye Valprobes, Metone and Matson Garvin particle size analyzer.• Assist vendor for the qualification of TOC, U.V Vis analyzer, vi-cell• Developed SOP for steam quality test, Kaye validator operation, Tank SIP sterilization and sanitization• Prepared Summary Reports for the Qualifications and Re-qualifications• Performed Risk impact determination (RID), Annex 11, 21 CFR part 11 for computerized equipment.

Minneapolis, Mn, Us

• Responsible for the development of qualifications and retirement documentation• Responsible for conducting and managing field execution of validation deliverables• Responsible for monitoring field execution of multiple projects related to validation and manufacturing process.• Assist in development and execution of the Cleaning Validation study for the facility equipment.• Responsible for generation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols for Implant equipment, Accu sealer, Audion Vac sealer, Fuji sealer, mixing tank, Bubble leak tester, Instron, autoclave.• Responsible for developing sop for the autoclave (Getinge, ETC), sealer, and facilities sops as per FDA recommendation.• Responsible for the Packaging analysis for Ploytyvek , foil, Kpak pouches.• Responsible for revising maintenance plans, Validation master plans (VMP), and standard operating procedures (SOPs) using quality standards set forth by cGMP’s • Assist in FDA and TGA inspection• Performed Gage R&R for volumetric liquid, solids and Instron Package tester.• Performed Filter Integrity test (Pall Filters)

• Developed and executed Process Validation Protocol and final execution summary report for different solid dosage forms like tablets and capsules.• Responsible for generation and execution Installation Qualification (IQ) and Operational Qualification (OQ) protocols for metal Detector, Deduster, Tablets press, Encapsulator, Capsule check weigher, HVAC system, mixers, tumblers• Responsible for developing and execution of the Blend hold time study.• PQ for the tablet press, Encapsulator, Metal detector, Capsule checks weigher.• Responsible for Managing the process validation improvement projects in 2nd shift• Responsible for managing protocol and report development, execution and approval associated with equipment qualification, cleaning validation and process validation. • Executed cleaning validation study for tumbler, fitz mill, and oscillator

Dublin, Ireland, Ie

• Prepared Requalification Assessment protocol and executed for departments like blending, coating, tableting, packaging, and encapsulation.• Prepared Equivalency report for the Dedusters, V-Blenders, Safe-line metal detectors, Korsch tablets press.• Prepared change controls for decommissioning of the equipment• Written exception, triage, CAPA for equipment and process failure.• Developed Blend hold time study and finished product hold time study protocol for pharmaceutical product.• Prepared IOQ for the Kramer Dedusters, totes, and V-blender, Tablet Press and Encapsulator.• Performed stability study by using data logger on stability chamber.• Developed Process Validation Protocol and Final report for tablets and capsules

Somerset, Nj, Us

• Prepared Installation Qualification, Operational Qualification, and Performance Qualificationof autoclaves ,incubators by using Kaye Validator .• Developed Cleaning Validation Protocol and calculated MAC for different soils• Developed protocol for Requalification assessment of the Equipment• Developed/revised procedures (SOPs)• Calibrated Thermocouples using Kaye Validator• Prepared Summary Reports for the Qualifications and Re-qualifications

Somerset, Nj, Us

• Performed and analyzed Dissolution, Bio-Dissolution, Assay, Blend uniformity, Content uniformity, Impurities of solid dosage forms like Sustained Release Tablets, Capsules, Orally Disintegrating Tablets, Immediate Release Tablets, Suppositories, by using HPLC, Fluorometry, U.V Spectroscopy, IR Spectroscopy, UPLC• Calibrated Dissolution bath, PH meter, Bio-Dissolution Bath, and Weighing machines• Performed Particle Size analysis by using Malvern(2000S) Particle size analyzer• Performed Cleaning Validation and cleaning verification study by using swabs from manufacturing department• Conducted stability studies, compatibility studies at different PH condition

Hoboken, Nj, Us

• Validation Master Plan for HBD Project• Performance Qualification of Convection Oven• Performance Qualification of Deni Press• Performance Qualification of Blender• Process Validation• Calibration procedure for Moisture analzer

• Duties included execution of process validation protocols for granulation, compression, and coating stage of solid dosage consumer products• Revision of standard operation procedures and Master Batch Record for Pharmaceutical Consumer Products• Prepared SOPs and maintained packaging batch records• Maintained and organized finished goods stock and dispatched it• Preparation and execution of qualification protocols and reports for manufacturing equipment.• Conducted time studies for manufacturing and packaging processes for Pharmaceutical products, Conducted capacity analysis for manufacturing equipment.

Ahmedabad, Gujarat, In

• Reviewed SOPs and maintained batch record• Documented and developed batch records as per GMP regulations• Performed calibration of equipments and maintained the track of all equipments.• Reviewed and revised manufacturing SOPs and maintained batch record

Master Of Science, Pharamacetical Manufacturing

Master Of Management, Masters Of Management