Love Patel

WORK HISTORY

EDUCATION

ABOUT LOVE PATEL

With over a decade of extensive experience in the Pharmaceutical/Biopharma industry, I bring a wealth of knowledge and expertise to my role. I hold a Masters degree in Biotechnology, which has equipped me with a strong foundation in the field. Throughout my career, I have consistently demonstrated my commitment to delivering high-quality results and staying abreast of industry advancements.KEY SKILLS:• Aseptic Manufacturing and Aseptic Process Simulation (Media Fill)• Upstream and downstream manufacturing processes in the biopharmaceutical industry• Quality and Compliance Oversight• QMS Activities - GxP Audits, Gap Assessments, QMS Process & Procedure Development, QMS Remediation• Validation and Qualification: Validation Master Plans (VMPs), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Equipment and Software Validation, Process Validation• Non-Conformance and CAPA Management: Investigation Support, Process Analysis and Enhancement, Action Plan Development, Effectiveness Check• Internal/External Audit• RCA - Risk Assessment and Root Cause Analysis • Market Complaint Handling• Process ImprovementSuccessfully navigated regulatory audits such as the US Food and Drug Administration (USFDA), European Medicines Agency (EMA), Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Gulf Cooperation Council (GCC), World Health Organization (WHO), and others.I am a quick passionate learner and enjoy taking on new challenges. I am well organized, responsible and reliable, as well as a proficient multitasker.