Darshan Patel Email & Phone Number

Oakville, Ontario, Canada

Oakville, Ontario, Canada

- Intake requests for deviation reports and generate records in Trackwise within specified timelines- Develop investigation plans and strategies- Coordinate immediate actions in conjunction with Quality as well as with department management upon identification of a non-conformance- Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple departments to investigate reported problems and assess the quality impact- Conduct investigational meetings with required team member(s).- Utilize problem solving and root cause analysis (RCA) techniques to determine root cause and contributing factors including root cause analysis meetings with key stakeholders- Work with cross functional team member(s) to develop appropriate CAPA actions- Assess risk using principles of ICH Q9 and internal procedures- Author investigation reports- Identify and analyze recurrence and trends arising from individual investigations- Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms- Act as liaison/SME as it relates to specific investigations with suppliers. Mentor CMOs and suppliers on robust investigation practices.- Generate and manage CAPA records. Implement CAPA plans and review CAPAs to determine their effectiveness- Intake complaint notifications and perform Complaint investigations, as required.- Support and/or perform tasks within other QA departments including product release, change control, compliance etc. as required- Support implementation of special projects, as required

Richmond Hill, Ontario, Canada

• Responsible to ensure all manufacturing investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP’s.• Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions. • Facilitate meetings with multiple Subject Matter Experts (SME’s) as required.• Perform thorough impact analysis in collaboration with all SMEs including Vendors. • Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. • Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.• Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.• Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager.• Lead, oversee, or participate in cross functional projects associated with manufacturing deviation reduction initiatives.• Assist Production Supervisors/Team Leaders in ensuring investigations are initiated and relevant information pertaining to the deviations are gathered in a timely manner. Act as technical resource and provide support & guidance to groups within Operations.• Work as members of a team to achieve all outcomes;• Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

Toronto, Ontario, Canada

1) Responsible for all critical, major and minor deviations associated with the Platform o Determine the scope of the investigation to Lead and develop investigation strategy by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.o Perform RCA by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.o Participate in Autonomous Production Team (APT) support team meetings for planning and execution of investigations.o Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines. 2) Develop appropriate corrective and preventive actions.o In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause.o Initiate CAPAs in the Quality System as required.o Support manufacturing staff on updating GMP documents arising from CAPAs. 3) Work with Platform Leaders to identify and develop process improvements to remediate risks. Develop Investigation cases to present at Governance boards.o Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.o Utilize the Deviation Review Board Governance as required.o Present and defend investigations and provide support to the area manager for process / procedure topics during Regulatory inspections and other audits. 4) Responsible for Shop Floor Compliance within the Platformo Lead and manage Data Integrity activities, initiatives and continuous improvements within the Platform in collaboration with APT Support teams and QOVS.o Perform Shop Floor Production Walkthroughs (GEMBA) to identify compliance gaps.o Track and develop action plan to address gaps, as required.

Richmond Hill, Ontario, Canada

1)Have required working knowledge to operate SAP, LIMS, and Trackwise systems2)Quality Systems•Lead investigations and CAPA implementations within the QAIP department and provide support to investigations and implementation of CAPAs to all areas of the business as required•Generate AQRS as an observing department when deviations from established procedures or acceptance criteria are observed•Report any deviations found during review of sterile and non-sterile in process batch documents to the Supervisor/Production personnel. Ensure all document corrections are made in the appropriate manner and ensure that all deviations are fully explained and supported by the necessary documentation•Complete the AQRS usage decision in SAP •Review and approve all minor non-conformances generated by other departments 3)Document Review•Review and approve applicable sterile and non-sterile Production documents according to established priorities and standards•Oversee the control and archiving of production/packaging logbooks and also review for completeness4) Quality Support•Provide QA oversight of all activities on the Production lines•Perform sampling, inspection and review of physical testing on in-process/investigational samples and reporting of results in SAP and LIMS•Conduct regularly scheduled inspection/audits of the production/packaging area•Support customer complaint investigations as required6)Validation (Cleaning Validation)•Support the cleaning validation program by sampling of equipment and release of equipment for cleaning validation, verification and monitoring activities.7) QAIP Support Activities•Performs reserved sample inspections and waste disposal as required•Ensure that training records are accurate and completed according to cGMP•Provides training to new Coordinators •Covers for the duties of the Supervisor in their absence

Richmond Hill, Ontario, Canada

• Handling and maintaining BMar (Batch Mfg. Record), BPaR (Batch Packaging Record) and MPaR (Master Packaging Record)• Control process start-up, shutdown, and troubleshooting. Adjust equipment, valves, pumps, and control and process equipment• Preparing equipment or process units for maintenance• Assembling/Disassembling Tubing, Pumps, manifolds, and other filler parts for the filling of Liquid Dosage forms• Filling Nasal Sprays, Ear Drops, Eye Drops (Sterile), Oral Liquid Dosage form, and Packaging them.• Operating electronic or computerized control panels, HMI• Carry out In Process Checks (IPCs) for Fill volume check, Vacuum leak test, Open/Close torque, and Oxygen Head space• Assembling, Disassembling, installing, and cleaning cartridge and/or capsule filters used for product or gas• Carry out pre-use and post-use filter integrity testing using Aquawit filter integrity system• Preparing and cleaning Isolator for sterile filling process. Running pre-run and post-run VHP cycles for sanitization and swabbing in Isolator• Carry out Reconciliations and Yield calculations after Batch finishes• Retain sample management for QA, QC, Stability, and Micro testing• Perform line clearance processes, changeover, cleaning of the filling room and line, putting room in process for the next batch• Troubleshoot filling and packaging machines problems to increase productivity and decrease downtime• Licensed to operate Walkie Lift Truck• Carry out sampling process as per sampling matrix• Strictly compliance with GMP, GDP, SOPs, GPOLs.• Managing production floors and teams to meet daily production schedule, making sure all components, bulk are staged as planned timeline• Transfer of technology and manpower from PPD (Product Process Development) to Commercial scale• Actively contributing in team meetings and other team related activities• Correctly completes all documentation accurately and in a timely manner as per SODs

Toronto, On

Toronto, On

As a part-time employee.Position: Chef, CSR, and Oven Operator.

Vadodara Area, India

• Carry out In Process Checks: LOD, Weight variation, Dissolution, Disintegration, Hardness, Thickness, Friability, and Drug content• Perform various bulk testing including Density, pH, Osmolality and Viscosity.• Perform routine sampling and content uniformity sampling as per the sampling plan specified in the Batch document.• Review of in process checks for friability, hardness, solubility tests and process parameters during manufacturing operations.• Review end reconciliation and perform end of batch clearance for change over• Handling sample management for Product evaluation, Microbiology, QC Chemistry, QC Stability, and QAIP.• Preparation of bulk broth media for cell culture expansion• Log samples in SAP and conduct testing to Quality Control and storage to retain.• Reporting of all the process deviations/maintenance jobs to seniors in timely manner• Perform AQL for finished products and conduct AQL inspection for product defects.• Preparing Bulk Mobile phases for the HPLC process• Successfully perform and carry out Drug Assays for required bulk samples.• Provide support to ongoing solid dosage form product during manufacturing process.• Perform line clearance after cleaning and review line setup and line startup.• Review Batch documents and other GMP documents used on shop floor for good documentation practice.• Conduct impact assessments for line stoppage and inadvertent incidents during filling and packaging operations.

California, Usa

As an online sales manager, my role was to update drugs descriptions, drug costs, and to manage brand names as well as generic drug products.

California, Usa

As an online sales manager, my role was to update drugs descriptions, drug costs, and to manage brand names as well as generic drug products.

Surendranagar Area, India

Industrial training in Tablet, Capsule, and Quality Control department.

Advance Diploma In Chemical Laboratory Technician, Chemical Technology/Technician, 3.5 Cgpa

Master Of Pharmaceutical Engineering, Pharmacy, Pharmaceutical Sciences, And Administration, First Class (66.50 %)

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Pharmaceutical Sciences, And Administration, First Class (66%)