Mahendra D.
Quality Assurance Operations Manager @Sanofi
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WORK HISTORY
Quality Assurance Operations Manager @Sanofi
Toronto, ON, CA
Vaccine Mfg : Aseptic Filling, Formulation, Fermentation)- Spearhead risk-based quality decisions, negotiating with Operations, Engineering, Logistics, and Planning teams to drive site success and ensure regulatory compliance- Lead cross-functional collaboration to implement strategic initiatives for continuous quality improvement across upstream, downstream, formulation, filling, packaging, and distribution- Serve as core Quality representative for IQ, OQ, and PQ reviews of new GMP instruments and consistency batches- Direct and coach teams on structured investigation strategies, RCA, CAPA, and CCR processes, resulting in faster, GxP-compliant batch release decisions- Oversee quality support for electronic system implementations (iFMS and DeltaV) for vaccine formulation processes- Develop and execute robust QA staff training programs, enhancing audit readiness and strengthening regulatory compliance- Proactively resolve shop floor observations using deep GMP knowledge, improving operational compliance.
EDUCATION
Alison
Diploma of Education in Six sigma
Gujarat University
Master of Science (M.Sc.), Industrial Microbiology and Environmental Biotechnology
ABOUT MAHENDRA D.
More than 8 years of working unsupervised and team leading experience.• Excellent in deal with various departments; this includes bulk/sterile manufacturing, formulations filling, packaging, quality control, quality operation, sterility assurance and aseptic techniques under current Good Manufacturing Practices(cGMP) environment. • Excellent ability to resolve the problems with practical remedial and corrective-preventive actions• 2018 Diploma in Six SigmaAcquired exceptional knowledge about GMP, GLP and regulatory guidance requirements includes USFDA, Health Canada, ISO 14644, MHRA, INVIMA, TGA, ICH• Pharmaceutical application: SAP, DMS, TrackWise, Zen QMS, Phenix and Laboratory Information Management System (LIMS) and Visio, Autocade, LONZA MODA• Training -GMP Supervisor February 2018: Successfully participated and completed the course “Leading the climb for compliance” from ValSource Training Solution.
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