Dan D'Silva,Pmi-Pmp® Email & Phone Number

Brampton, On, Ca

Alliston, Ontario, Canada

Toronto, Ontario, Canada

• Led several qualification and requalification activities of new and existing equipment, utilities & and facilities (HVAC, CCA, Pure water system) filling lines, packaging & and processes with a focus on GMP following a Master Validation Plan.• Developed and executed several IQ/OQ/PQ protocols for equipment qualifications and requalifications, Cleaning Validation protocols, Process Validations, and temperature Mapping using Kaye validator and Data Loggers and Drafted validation summary reports.• Led the process validation of several OTC and Non-OTC products to ensure the CTQ and CPP specifications were met (e.g. weight, pH, viscosity, texture, odor, etc.)• Drafted several URS & FRS, Risk assessments, and Change Controls and provided extended support and guidance to support validation activities.• Performed comprehensive risk assessments to evaluate the cleaning matrices scoring criteria and identified the worst-case scenarios.• Led CSV activities for the Instruments Installed at the R&D Lab in accordance with the 21 CFR Part Requirements. • Managed and provided expert guidance to the validation assistants and QC technicians to complete the validation activities and deviation closure activities. (CAPA Reports)• Updated and maintained the Validation Master Plan by evolving regulatory requirements and organizational needs.• Coordinated with Cross-functional team to ensure the planned validations were completed within the tight deadlines and assisted with the implementation of ISO, QMS, and other Quality-related initiatives.• Created and revised several (SOPs), Cleaning, and process validation checklists, and conducted several Internal Audits to continuously improve Apollo’s processes.• Developed several study protocols as a part of cleaning validation CI initiatives and won the Star Performance award for developing successful protocols for the removal of Biofilm from Apollo’s production equipment.

Greater Toronto Area, Canada

Validated the URS, IQ & OQ validation protocols for equipment and instruments in the resilience production facility following the master validation plan.Provided proactive support for the planning & development of several projects including equipment installations, SAT, Calibrations, Risk management, validations and system handover functions within tight deadlines. ( Upstream & Downstream processes).Monitored project deliverable against scope and worked with project teams to identify risks, contingencies and resources to maintain project schedule and ensured strict adherence to project’s Critical path.Contributed to the Risk based assessment of critical RBI assets and collaborated with the cross functional team to continuously evaluate and mitigate the risks. Drafted preventive maintenance plans (MCCP’S) for the RBI Instruments with reference to manufacture manuals, instrument criticality and risk assessments.Prepared a 5-year project plan Gantt Chart in MS Project and presented to the higher management for approval.Updated the site drawings in AUTOCAD and made changes for validation.Lead the Initiatives to close Deviations and CAPA’S within the deadlines which helped the project to strictly adhere to the planned schedule.

Toronto, Ontario, Canada

• Responsible to ensure that B100 preventive maintenance and calibration programme of more than 4000 Instrument in the production facility is in compliance with the SPL standards and procedures.• Managed and provided guidance to a team consists of Metrologists, C&Q, Quality and process engineers. • Driven several B100 deviations by initiating regular meetings with the C&Q, system owners, quality and other engineering workstreams.• Conducted FCCA technical reviews, Instrument registration reviews, Procal calibration review and approvals, work order approvals-SAP & Geode technical documentation review & approvals.• Driven several B100 deviation reviews related to metrology calibration and ensured deviation investigations are closed within targeted deadlines.• Reviewed and investigated the scope of deviations, impact assessments, root cause analysis and closure strategies.• Managed and prioritized high priority CTS execution tasks with a sense of urgency and giving key attention to detail.• Drafted high level technical justifications and Memo’s related to instrument calibration non-conformances, tracking and punch list closures in Fieldwire.• Provided extended support to C&Q activities, deliverables and provided guidance to execute CTS ( IV,OV & PQ Activities) for B100 metrology calibrations.• Collaborated with MTech, OQ, C&Q and other process engineers to analyze and Investigate root cause of failures related to calibration and CTS execution failures.• Managed sanofi vendors to ensure the calibrations performed are in compliance with the process expectations and in compliance with site SOP guidelines.

Toronto, Canada Area

• Updated and maintained QC work instructions and procedures, Checklists, Material Inspection Instructions, and CAPA procedures of MOVES SLC Thornhill-ventilator.• Analysed and Investigated RCA of nonconformities observed in material inspection and manufacturing Issues.(Utilizing Cause and effect diagrams and other problem solving tools).• Conducted quality assurance testing of ventilators to support design verification and validation efforts as per technical protocols. • Generated and investigated Non-Conformance Reports for critical parts, Functional test failures and Calibration test errors in Thornhill Medical’s FOGBUGZZ case software and implemented Corrective Actions after root cause analysis.• Performed the Inspection of Critical Components of thornhill ventilators and ensured parts are manufactured as per design specifications and quality standards.• Developed AQL sampling plans for quality control Inspection and validating design CTQ parameters for process validation and Incoming Inspection support.

Brampton, Ontario, Canada

• Provided significant contribution to design, V&V and prototyping activities of the newly developed electronic ventilator (eAdvantage) as per ISO 80601 ventilator design standards. • Assisted QC manager in the preparation of filing regulatory reports to Health Canada, including medical devices problem reports and recall reports and ensured all local procedures are current and met the requirements.• Developed the IQ and PQ protocol for O_two Ventilator and validated the same.• Monitored the calibration of device used in Lab (Heart-lung machines, calipers, fixtures, gauges etc) and maintained calibration records as per quality standards. • Documented and updated DHF, Device master record, Design Input files and Design output files of O_two e-ventilators and pneumatic ventilators as per device standards and compliance.• Created and validated various mechanical test reports, SOP’S, and Risk management documents to support V&V activities of electronic and pneumatic ventilators. • Provided extended support to Product Surveillance activities by analysing various product failures, Customer complaints and Investigated root causes for recalled ventilators and prepared detailed reports.• Inspected small and delicate components as per design standards and executed CAPA for Non-conforming parts.• Investigated the Compliance gap of newly revised and existing standards used in the ventilators to ensure device safety and design requirements and recommended for new test plans to validate the identified gaps.

Worked for major clients from USA/Europe (i.e) Johnson and Johnson group of Companies (US), Depuy Synthesis, Quest medicals (USA), Baxter, American Medical Systems & Kerr.Electromechanical Medical equipment experience- Design and development of MPS3, Incubetors,AMS700,Defibrillators, Spinal implants, Kerr Demi pro ultra. Delivered design and drafting support in Solid Works & Creo for various Orthopaedic and other high precision electromechanical medical equipment. Support documentation of Standard Operating Procedures for manufacturing and verification fixtures for electromechanical medical equipment.Developed mechanical requirement specifications (MRS) & test method protocols based on visual inspection, functionality & performance requirements.Designed, developed and built high precision test fixtures for electromechanical medical components and documented standard operating procedure for manufacturing and verification activities.Created change requests and change orders in compliance with the design modifications and maintained the data’s and reports in SAP, ECentral & and Agile PLM.Liaised with process engineers, vendors, suppliers and production staff to support the final assembly and 3D prototyping of parts. Managed troubleshooting activities in assembling high precision medical equipment and supported for fixture validation activities. Audited projects in compliance with ISO 13485 and as per FDA guidelines and provided technical guidance to meet organizational quality metrics and process validation methodology.Followed in-depth DFMEA analysis & root cause analysis and provided corrective actions to ensure product integrity and reliability.

Bengaluru Area, India

• Instrumental in design and development of sheet metal and automotive components as per customer requirements.• Designed jigs and fixtures for part machining and various press tools like combination, compound and progressive dies for various automotive and machinery products.

Cochin Area, India

Designed high precision progressive stamping tools, Jigs & Fixtures for automotive components.Inspected production engineers and tool makers for tool assembly ,Conducted internal audits and training's as per compliance with ISO 9001:2008 quality procedures.Oversaw geometric check of all parts, interference and clearance analysis of the assemblies

Bachelor'S Degree, Engineering/Industrial Management

Activities and Societies: IIIE Member

Post Diploma, Tool Design

Diploma, Tool & Die Making