Mandeep Dhillon
Sr Quality Consultant @Pharmatech Associates, a USP company
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WORK HISTORY
Sr Quality Consultant @Pharmatech Associates, a USP company
Independent Consultant Dhillon Consultancy Services
EDUCATION
San Diego State University
Advanced Certification in Regulatory affairs, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
SKILLS
ABOUT MANDEEP DHILLON
Served as an expert consultant on large complex international compliance project involving corporate 483 responses, Warning letters, Consent decree, and AIP. Managed and successfully prepared for PAI (Pre-approval Inspection) of a Combo product (drug-device) for a manufacturer and its suppliers. Conducting GMP (21CFR part 210 and 211) and GLP inspections of facilities. Primary area of focus includes production and batch records, stability data, validation and qualification data.Well versed with FDA requirements for Conducting and Writing OOS investigations, non-conformance programs for a pharma industry.Provided oversight and audits over manufacturing and laboratory areas for evaluation and review of quality systems. Lead laboratory through several successful audits and inspections. Develop, establish & implement quality management systems customized to client needs especially Document Control System using Master Control PDM Software Solution and CAPA. Creating FMEA, Process Map, Process Report, Writing and Execution of Validation Protocols including Installation, Operational, Performance, and Process Validation protocols for the facilities, systems and equipment used in manufacturing and support systems. Review and assess impact of protocol deviations. Performing lead auditor function in the execution, management and closure of Quality Management System issues. Validate new processes, development and implementation of IQ/OQ/PQ, analyze data for validations, aid engineering quality staff on risk assessment, verification. Writing and execution of validation protocols including Installation, Operational, and Performance, Qualification of mechanical systems within the buildings, including hot water systems, air handlers, nitrogen, CDA, Vacuum and other major building support devices and equipment. Coordinate with manufacturing and engineering to correct non-compliance and recommend process changes to meet quality system requirements
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