Mandeep Pathania Email & Phone Number

Working in Quality Assurance department from 2007 till date. Started my career in Panacea Biotec- Vaccine Unit- baddi.Throughout my career i have worked in sterile units I.e vaccines, opthalmics & biosimilar products, Insulin.Main area of responsibility is Qualification & Validation. Keen area of interests are facility, utilities, equipment commissioning, qualifications & validation. Designing of aseptic media fill simulation systems. Implementation of quality system in place so as to keep the systems as per the current regulations. A good team member with supportive & innovative ideas. Knowledge of PLC & Computerized system validation as per 21CFR & GAMP 5. Engineering related compliance for calibration and PM management. Key author for password management SOP in 3 organizations.Have also worked in cross functional team I.e QMS & In process. Batch record review.Good at conducting internal audits for gap analysis. Qualification of legacy Facility & equipments as pet the ISPE.Good in preparation and review of Quality system documents I.e. SOP, protocol, VMP, change controls, CAPA, deviation, Batch records, etc.Part of team responsible for conducting periodic vendor audits of vsriour service providers.Risk based qualification of equipments as per the current approach for qualification. Well versed risk assessment tools.Good at conducting training sessions for new as well as old employees.

Listed skills include Cgxp, Quality Assurance, Qualification And Validation, Utility Qualification Hvac And Water System Qualification, and 28 others.