Bhupendra (Bob) Patel

Experience

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  Excel Industries Limited

  Dec 1995 - Jun 2006

  Supervisor and Chemist

  •Planned, scheduled activities of Environment department (including engineering) and audited Production plants using HAZOP and Fault Tree Analysis•Responsible for the operation and maintenance as well as quality control of Activated Sludge process for Waste Water Treatment Projects (developed Microbial Strains)•Supervised the operation of Incinerator plant comprising of two stage combustion chamber and flue gas scrubbing system•Developed, commissioned and supervised Biotower (Aerobic thin film) technology and Upflow Anaerobic Sludge Blanket (UASB) technology for Waste Water treatment, monitored performance and prepared reports•Performed Preventive Maintenance and Calibration of laboratory equipments•Monitored and analyzed samples of effluent treatment plant, ambient, stack and work area air quality •Performed microbiological identification and analyses using pour plate and spread plate methods•Performed internal Safety audits and documented/communicated required changes to processes for OHSAS 18001 requirements•Organized workshops to create Environment Awareness for production supervisors and other employees•Developed company’s Green house: layered soil, planted and pruned vegetable and flower plants. Conducted experiments related to seed development and plant care Show less

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  Spherion Staffing Solutions

  Sept 2007 - Mar 2008

  General Help on Contract basis in Nestle Canada Inc. (ISO 9001, ISO 14000, OHSAS 18000)

  •In-line quality check and sampling of wafers and bars, sorting out those that failed to meet specifications.•Participated in ISO accreditation process by reporting hazards to Team leader as well as giving suggestions on procedures to improve sanitation (eg. spill containment).

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  Maxxam Analytics

  Apr 2008 - Jun 2008

  Laboratory Technician

  •Operated Hydra Prep Automated Mercury Preparation System for digestion of samples for CVAAS•Prepared worksheets related to sample specifications using LIMS and SAIL software

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  Germiphene Corporation

  Jun 2008 - Sept 2011

  Calibration/Validation Coordinator

  Reported to the Quality Assurance Manager. Responsible for planning, scheduling, performing, reviewing, getting approved and maintaining records of repairs, qualification, performance maintenance and verification of more than 25 lab equipment (semi-annually), more than 100 production equipment (fortnightly to annually) and 35 metrology equipment (mostly annually) using Calibration Manager software (Blue Mountain Inc.).•Generated protocols and executed validation/qualification of IT, process, laboratory and production equipment.•Participated in decisions for Contracts with Waters, Varian, Fisher Scientific, OPCS, Gamma Scales etc.•Facilitated the qualification of Varian AAS and 3 Waters Alliance HPLCs - reviewed documents before approval by QA Manager.•Wrote new/revised SOP’s for Operation, Calibration, PM and PV of Analytical equipment and trained Chemists for better GMP practices.•Supported the QA Manager for preparation and Management of Annual Product Quality Review of more than 10 products as per regulatory guidelines.•Accountable for the Siemens Pure Water Plant (30GPM) in the absence of Production Manager.•Reviewed and signed log books of equipment like PWS - Passivation/Sanitization, Balances, Differential Gauges and Environmental Monitoring in QC, microbiology and production for completion and errors.•Commissioned/Decommissioned laboratory (QC and Microbiology) and Production equipment.•Evaluated Vendors for Qualification, Calibration, Preventive Maintenance and repair services.•Coordinated the repairs, performance maintenance and verification of laboratory and production equipment.•Performed temperature mapping of the warehouse, incubators and refrigerators as well as environmental monitoring of cleaning room to comply with GMP requirements.•Conducted internal audits and report to management assuring compliance with GMP regulations.•Documented Deviations & NCRs, Investigate and implement Corrective and Preventive Action (CAPA) to close them. Show less

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  Alphora Research Inc.

  Oct 2011 - Jun 2015

  GMP Laboratory Equipment, IT & Metrology Specialist

  Reported to the Q&C and AS Managers. Responsible for planning, scheduling, performing, reviewing, getting approved and maintaining records of repairs, qualification, PM/PV of more than 40 HPLC/GC (semi-annually) and 15 metrology equip (annually). Being the Empower software Admin and the ERP Superuser, responsible for the Security of Lab IT and ERP systems and a WebEx gateway for maintenance and troubleshooting of ERP systems.•Facilitated Validation programs for 8 Waters Acquity H-Class UPLCs (1 w/QDa Mass Detector), 5 Agilent 1290 Infinity HPLCs (1 RID), Agilent 7700 Series ICP-MS system, Agilent Micro-EC Detector on 7890A GC, 3 Waters ELS Detectors (1 on Agilent HPLC), 4 Data Backup Systems, 3 Servers and 2 Printers - reviewed documents before approval by Q&C Manager. •Participated in Contract decisions for Waters, Agilent, Miele, Fisher Scientific etc.•Evaluated requirements, generated and completed Change Controls impacting SOP, Validated Equip, Systems or GMP processes to support Q&C management decisions.•Wrote/Revised 5 SOP annually for Operation, PM/PV of analytical equipment or computer systems and trained Chemists.•Generated 15 Work Instructions for the Computer Systems to maintain consistency in all GAMP procedures.•Initiated and participated in investigations of Deviations, NCRs, OOS of PV/analysis results to find the root cause and bring them to closure in a timely manner.•Documented repairs/changes in equip on specific log book and reviewed them for completion to avoid non-compliance.•Created, backed-up & archived 50 projects, restored 5 – 8 projects for Empower Software & managed 7 servers on a monthly basis to support business acquisitions.•Performed weekly Back-up of Standalone LC-MS, GC-MS n Stability data System.•Created logins, reset passwords, maintained Security of IT systems including Empower, ChemStation and ERP.•Qualified Vendors for PM/PV services to get prompt quality services without impacting the spending for the services. Show less

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  Nucro-Technics Inc.

  Oct 2015 - Apr 2017

  Compliance Associate

  Reported to the Director of Compliance. •Responsible for Validation, Performance Maintenance and Performance Verification of Dissolution apparatus with Dissoette, pH/mV/Conductivity meters, Vapor Pressure Osmometer, Refractometer, Orbital Shaker, Mercury analyzer, Circulating heat/cooling Water Baths, Purified Water Systems, Stability Chambers and GLP equipment like Elisa Plate Reader, Electrocardiogram, Grip Strength meter. Activities planned and scheduled using Calibration Manager software (Blue Mountain Inc.).•Expedited Calibration and PM of Tablet Hardness, Disintegration and Friability Testers.•Performed and interpreted data of mapping of Deep Freezers, Stability Chambers and Walk-in Chambers.•Initiated and participated in the investigations of Deviations, Out of Specifications and Out of Calibrations.•Reviewed equipment PM and PV documents from colleagues, Chemists, Microbiologists and vendors.•Ensured Chemists/Microbiologists/Scientists were informed before scheduled date of PM/PV; coordinated with external service engineers and technical support to schedule visits and troubleshoot equipment. •Created new Standard Operating Procedures (SOP) for new MilliQ Pure Water Systems.•Trained Chemists and Microbiologists to use new equipment or to follow revised SOP.•Biennial review of SOP for Performance Maintenance and Performance Verification of above equipment and revision of SOP.•Accountable for the maintenance of temperature and relative humidity in about 15 stability Chambers. •Accountable for the Performance and PM of 4 Laboratory scale USP Purified Water Systems. Show less

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  Dalton Pharma Services

  Apr 2017 - Aug 2019

  Calibration Validation Specialist

  • Reformed Cal procedures and specs according to tolerance & process requirements after discussing risk factors with QA.• Participated in regulatory compliance response to Health Canada GMP inspection, reducing 50% of observations compared to previous regulatory audits; received only minor deficiencies.• Part of the Team that hosted first PAI, achieving no ‘483 Observations’; resulted in brand product Marketing Authorization in USA.• Appreciated for in-depth knowledge/presentation skills of Clean Utility Systems by Quality Auditor before acquisition.• Supported QA/QC Reviewers for decision making on release of RMs, In-Process & FPs.• Actively participated in Cross-functional teams to assist closure of Non-Conformance documents.• PM/Cal of Freezing Osmometer, Dissolution, Polarimeter, ELISA Plate Reader, Oxygen analyzer, Muffle Furnace, Incubator, Water Bath.• PM/Cal of instrument on Restricted Access Barrier Systems, Filter Integrity Tester, Millipore RO Filtration Unit, VirTis Ultra Lyophilizer, Lytzen Depyrogenation Oven, Parr Reactor.• Cal of online Vaisala data-loggers for Temp, RH and Differential Pressure, on the BMS - monitored by Yokogawa DAQ / Vaisala Veriteq ViewLinc.• In-house Cal of Temp. probe/monitor/data logger/transmitter (using IRTD, Dry well, Calibrator MC-1200), Pressure probe/monitor (3D and Druck Precision Gauge), Vaisala/Rotronic Temp. & RH probe/ transmitter (Kaymont Humidity Generator, PuTTY Terminal Application/HW4 software), MadgeTech Dataloggers for Autoclave Validation & Setra DP Gauges/Transducers (MicroCal Calibrator/ Shortridge AirData Multimeter).• PMed Parker Zero-Air, Dominic Hunter Hydrogen & Nitrogen generators.• Optimized USP Purified Water, Pure Steam Generator & WFI skids. PM/Cal including 643&PAT700 TOC analyzers. Sanitized PWS Quarterly.• Reviewed qualification of new Dissolution system, Agilent HPLC/UHPLC, Malvern Mastersizer/Zetasizer.• Used QM Software - QCBD for Trainings, Cal./PM management. Show less

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  ANI Pharmaceuticals Canada Inc.

  Aug 2019 - May 2021

  Senior Laboratory Calibration Chemist/ Lab Systems Specialist

  • Advised and supported IT Department on administration of Empower Enterprise network software. Point of contact with Waters Corporation, Agilent, Perkin Elmer and others for all software related issues and troubleshooting.• Generated and executed protocols for Performance Qualification of Server, LAC/Es and Clients for HPLCs and GCs on the Empower network related to upgrade of Empower 3 Feature Release (FR) 2 to FR 5.• Troubleshoot HPLC and GC systems for connection to LACEs and configure new systems to connect. Ran qualification/Verification of Agilent HPLC systems using Waters SQT tool.• Qualified new Vendor for Repair of HPLCs and Annual PMs of GC systems.• Assigned roles to Chemists on UV/VIS Chemstation and FTIR Spectrum IR systems.• Calibrated, troubleshoot and PM of Agilent HPLCs (1100 to 1290 - Annual in-house), Agilent GCs, Agilent UV/VISs (Cary 8454 - in-house), Perkin Elmer FTIR, Mettler Toledo Karl Fisher (V30) and Auto-titrator (D53), Tablet Dissolution, Tablet Disintegration, Furnace, Stability Chambers, Photo Stability Chamber, Viscometer, Chart Recorders, Mettler Toledo Balances and Mettler Seven Excellence pH meters.• Performed maintenance of the MilliQ Purified Water System for Analytical Lab usage and Stability Chambers.• Qualified new vendor for mapping of walk-in Stability Chamber, Stability Chambers (including Light Stability Chamber), Incubators and Freezers/Fridges. Show less

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  Sanofi Pasteur

  Jul 2021 - Feb 2022

  Metrology/Validation Consultant

  (Commissioning, Qualification, Production and Testing)• Responsible for gathering data from Functional Critical Component Assessments (FCCA) documents and creating registration forms (Instrument Registration and ProCal Registration Templates) for all systems.• Determine/Update Calibration frequency of instruments based on Criticality scores and Cal points/ Cal Tolerance Limits based on Process Operating Range and Process Required Accuracy in the FCCA.• Initiate, investigate and follow-up Change Controls and Deviations to complete before targeted deadlines.• Prioritize work per C&Q activities and follow-up with reviewers and Log Admins per needs to execute CTS/CTP (Operational Verification activities) for B100 Metrology Calibrations.• Familiar with using CTOD, VTOD, P&ID, RTM, Slope Verification and Critical Component documents for reference.• Used software like ProCal, SAP, iShift, GEODE+, Gibraltar, Fieldwire on a regular basis.• Train and review work of colleagues for Instrument Registration and ProCal Specification updates. Show less

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  Amaris Conseil Inc.

  Sept 2023 - now

  Validation Senior Consultant