Harshit Patel Email and Phone Number
Harshit Patel work email
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Harshit Patel personal email
* Knowledge of FDA Regulations, 21 CFR Part 210, part 211, part 11, part 820, DEA Regulations and Indian regulations for Pharmaceuticals and Biotech Industry.* Having Resourceful Knowledge of CAPA, Root Cause analysis, Quality tools like FEMA, Fishbone and 5 why.* Experience in Using KAYE 2000, KAYE AVS, KAYE ValProbe Loggers and, ELLAB Thermal Validation System.* System Development Life Cycle: Experience in Developing Validation Plan, RiSk Assessments, SOPs, URSs, IQs, OQs, PQ/UATs, CS and DQs, RTMs and Validation Summary Reports for Computer systems and Complex GxP equipment. * Commissioned Air handler for the Warehouse Project and assisted with development of strategies for BAS system.* Involvement in Execution of Microbial swab sampling for CEHT, DEHT and LOTC study. Experience in using various Air Sampler for Environmental Monitoring.* Handling of DHS, Autoclave, Ampoule and Vial tunnel, Vial filling and Sealing machine, Fluid Bed Dryer, Freeze Dryer and BFS Machine during Parenteral Productions.* Handling and Skillful Knowledge of HPLC, Dissolution test apparatus, UV Spectroscopy and FTIR.* Skill set and Tools: QUMAS, eQRMS, Veeva Vault, Infinity, Blue Mountain RAM, Compliance wire, JD Edward, MS Office, MS Project and Outlook.
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System And Equipment Validation EngineerBristol Myers SquibbNew Jersey, United States -
Manager, Cqv Portfolio DeliveryBristol Myers Squibb Nov 2024 - PresentLawrence Township, Nj, Us
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Supervisor, Cqv Project DeliveryBristol Myers Squibb May 2023 - Nov 2024Lawrence Township, Nj, Us
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Specialist, System And Equipment Validation EngineerBristol Myers Squibb May 2022 - May 2023Lawrence Township, Nj, Us
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System And Equipment Validation EngineerBristol Myers Squibb Jul 2019 - May 2022
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Quality Assurance Inspector IiiAmneal Pharmaceuticals Apr 2016 - Jul 2019Bridgewater, New Jersey, Us* Responsible for Area clearance and stage wise clearance activities for next stage of production. *To Monitor Shop floor activities and report Non-complience in term of deviation, out of specification or any incident that may have direct adverse effect on Quality of the products, system and facility.* Prepared and reviewed documents related to ANDA Exhibit Batches and Validation batches such as MBR, PBR and protocls in order to maintain smooth formulation activities of product developement.* Review and Involvment in making SOP(s), related to process, Equipment/Instrument and systems.* Review batch manufacturing records for final released.* Review and involvement in making SOP(s), related to process, Equipment/ instrument and systems.* Perform Swab/Rinse sampling of New Equipments during Qualification and On all equipemtns that used during Mfg of Validation Batches.* Perform Enviromental Monitoring Air Sampling for Viable Counts.* Review of Equipment Qualification protocols, Process Performance Qualification Protocols, Process study Protocols, Cleaning Verification/Validation protocols, Investigational product sampling protocols and Stability Protocols.* Give Contribution In Incident Investigation and Closing of Incident. -
PharmacyGlobal Medicine And Surgical Instruments Nov 2014 - Apr 2015* Regular stocked shleves, rotated stock and checked for expired medication.* Perfomed technical processes required to dispensed medication to patients.* Inspected drug storage sites, monitered drug supply expiration dates and ensured proper supply levels.* Checked prescription for appropriate dosage, drug interation, allergies before dispensing medications.
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Production Officer Of Parenteral ProductsUnimed Technologies ( Division Of Sun Pharmaceuticals ) Mar 2013 - Jul 2014* Performed Steam sterilization and Autoclaving activity for Injectable as well as ophthalmic dosage form.* Batch Manufacturing and Filtration process for SVP Products.* Handling of DHS, Autoclave, Ampoule and Vial tunnel, Vial filling and sealing machine, Fluid Bed Dryer, Freeze Dryer and BFS Machine.* Enthusiastically assisted in IQ, OQ and PQ of Clean-In-Place and Sterile-In-Place unit and FBD.
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Qc Control Chemist IiiRelax Biotech Pvt. Ltd. Feb 2012 - Mar 2013* Performed daily Analytical Practical on HPLC ( High Performance Liquid Chromatography ), Dissolution Testing, UV Spectroscopy, Polari meter, Polarography, pH Meter.* Performed Numerous analytical and chemical testing on finshed products as well as Raw Materials.* Resourcefully Involved in Method Developement.
Harshit Patel Skills
Harshit Patel Education Details
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R.C.Patel Institute Of Pharmaceutical Education And ResearchPharmacy
Frequently Asked Questions about Harshit Patel
What company does Harshit Patel work for?
Harshit Patel works for Bristol Myers Squibb
What is Harshit Patel's role at the current company?
Harshit Patel's current role is System and Equipment Validation Engineer.
What is Harshit Patel's email address?
Harshit Patel's email address is ha****@****bms.com
What schools did Harshit Patel attend?
Harshit Patel attended R.c.patel Institute Of Pharmaceutical Education And Research.
What skills is Harshit Patel known for?
Harshit Patel has skills like Corrective And Preventive Action, Quality Control, Pharmaceutical Industry, Change Control, Standard Operating Procedure, Bfs, High Performance Liquid Chromatography, Quality Assurance, Computer System Validation, Cleaning Validation, Equipment Validation, Fluid Bed Dryer And Freeze Dryer.
Who are Harshit Patel's colleagues?
Harshit Patel's colleagues are Sushma Kammagani, Faradae Renner, Libby Massie, Adriana Oliveira, Damien Clement, Jerry Yu, Alessandro Made'.
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