Dharmesh Patel, M. Sc, Cqa Email & Phone Number

Mississauga, Ontario, Canada

 Organise, lead and follow up the supplier audits (Manufacturers (API, Excipient, Medical Devices, Consumer Products, Chemicals, Pharmaceuticals) Service Suppliers, 3PL Warehouses, Testing Labs, Transportation) Manage audits which includes contacting auditees to plan the assessment, making appropriate travel plans, conducting audits, completing reports and managing results  Responsible for preparing and presenting summary/KPI reports to the management review meetings as required.  Supplier validation and qualification following the procedures and regulatory standards Lead and participate at external and corporate audits  Certified Lead Auditor, responsible for managing site internal audit program  Manage the supplier complaints and solve them, assist with the quality and technical agreements  Assist in the investigation of failures & continuous improvement creativities Provide regulatory and technical guidance for CAPA closure and remediation  Support quality assurance department activities and process improvement project as required Support Pharmacovigilance/complaints department as required Provide training and certification of new auditors Deliver constructive feedback to supplier and customers to comply with regulatory requirements Responsible for establishing and maintaining quality agreements with suppliers and distributors

Milton, On

 Organised, coordinated & hosted customer audits and government inspections to GMP/GXP and ISO & ensured a satisfactory outcome Managed and directed the internal audit program, investigations, and staff to ensure that policies, procedures, and internal controls were designed and functioning to effectively and efficiently accomplish organizational goals Analyzed internal controls, reviewed operations, presented recommendations to management, completed audits within the established time schedules and in accordance with department standards, wrote concise and professional audit reports, and developed audit programs  Maintained supplier audit program while providing support to other logistic distribution centres in the US. Site certified auditor/lead auditor; was responsible for conducting external audits for ISO and routine GMP/GXP with regards to suppliers for contract manufacturing, packaging vendors, testing labs, service providers, other suppliers. Delivered GMP/GXP and ISO related training to the staff and management team and maintained training records QA assessor and SME approver for local change control and NC/CAPA program and was responsible for the maintenance of supporting documents/files. Responsible for assessing and approving product return to saleable stock or destruction Responsible for ensuring the release of safe and efficacious products into the Canadian market through documentation review (batch records, analytical reports, stability records, associated deviation and OOS reports) and determination of acceptability.  Assessed and implement global quality policy and associated procedures and standards at the site level  Managed DC/LC temperature monitor system, Pest Control and Sanitation program Managed CMO for manufacturing and embellishment operations, collaborates with management to establish and meet targets and timelines.

Mississauga, Ontario, Canada

Review, release DIN, NPN Products, Doing Audits, handling complaints, returned products

Mississauga, Ontario, Canada

Oversee operations of Quality Assurance department, responsible for product release, quality investigations, customer compliance, Quality Agreements and change control to support both commercial and product development businessesResponsible for preparing all documentation for Audits in compliance with current rules and regulations. Represent Quality Assurance department in regulatory and client audits Successfully completed ISO 13485:2003 Certification projectAudit internal facilities to ensure procedures are followed and meet corporate policy and internal standardsManage internal audit program by conducting internal audit as required and ensure that timely corrective and preventive actions are implemented Communicate with appropriate departments and third party manufacturers when inconsistencies in cGMP occurEnsure that products released to market meet quality, safety and efficacy standardReview and approve products after reviewing C of A, C of M and ID tests from lab Inspect returned products from customers, verify compliance and authorize their return to stock or destructionAssist in the development and approval of Standard Operating Procedures and Deviation ReportsIssue approved SOPs for training to appropriate departments and maintain training records

Mississauga, Ontario, Canada

Responsible for product inspection, sampling and releaseMaintain warehouse temperature recordsAssist QA Manager in Warehouse Temperature MappingResponsible for Transportation temperature device calibration and maintenance of recordsManage SOP renewal process and training records for the RAQA groupResponsible for maintaining SOPs on company IntranetResponsible for preparing documentation for Health Canada AuditsAssist QA Manager in Supplier Evaluation Process

Mississauga, Ontario, Canada

Performed routine testing and analysis of raw materials, in-process and finished productsConducted stability studies for different productsInspect in process and finished products in compliance with specifications. Review and approve batch records Prepared documentation for internal and external audits and if required conduct internal audit and ensure all corrective and preventive actions are implemented on timeResponsible for preparation of ISO 9000 and ISO 14000 Audit DocumentationAssess and recommend approval or rejection of new contractors through the vendor qualification programProvide quality and compliance support Department Safety Coordinator, conducted weekly and monthly meeting of the Department

Certificate Course, Advance Quality Assurance

B.Sc; Bachelor Degree, Chemistry; Chemistry

M. Sc., Analytical Chemistry