Kunnjal Rajgor
Country Quality Head, India Affiliate @Sanofi
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WORK HISTORY
Country Quality Head, India Affiliate @Sanofi
Mumbai, IN
Steering Quality Operations for India affiliate to ensure product quality and regulatory compliance are maintained. Adhering to internal quality standards, regulatory requirements, and service level agreements, incorporating service quality and process improvement projects, maintaining close coordination with internal systems and processes, and assisting with ad hoc administrative activities. Corresponding with customers and partners, addressing problems and issues, and managing project documentation and deliverables. Identifying areas of quality failures and advising on system & process changes; participating in monthly QACI (Quality Assurance Capabilities Index), QRI (Quality Rating Index) and MRM (Monthly Review Meeting) • Conducting Root Cause Analysis of quality issues and implementing corrective & preventive actions; introducing various value-added processes in order to reduce / eliminate customer complaints. Delivering trainings for staff & workmen across levels and motivating them to perform better.
EDUCATION
Department of Biosciences, Vallabh Vidyanagar, Anand, Gujarat
Master’s Degree, Microbiology, General
Rushford Business School
Doctor's Degree, Business Administration, Management and Operations
ABOUT KUNNJAL RAJGOR
A dynamic professional with 20+ years of experience in Quality Assurance and Regulatory Affairs. Leading role in cGMP implementation and inspections in compliance with MHRA, EMEA, MCC guidelines and Pharmaceutical Standards.Adept at handling day to day operations in co-ordination with internal / external Stakeholders for smooth business operations.Proficient in managing projects & validations of various product launch, facilities and equipment’s in enhancing operational effectiveness. Adroit in implementing quality improvisation initiatives for enhancing the product quality. Effectively handling Discrepancy Management system, Change Controls, OOT, OOS, CAPA, Risk Assessment, Product Complaints, Counterfeits and Recall. Deft in handling all regulatory documents required (Like: Clinical trials, BE studies, COS / DMF of API, TSE / BSE certificates of API & excepients, punch approvals, food grade certification of primary packing material, approval of artwork of packing material, etc). An effective communicator with excellent relationship management skills and strong analytical, problem solving & organisational abilities. Expertise in local FDA/CDSCO / DCGI liasoning and other related matters. Handled liquid orals, solid orals, injectables, medical device and new applications like transdermal patches, drugs of all category including narcotics, biological, antibiotics, anticancer, new drugs etc. Skilled in third party selection, development, management and monitoring for outsourcing the activities related to manufacturing, analysis, warehouse or distribution. Efficient in handling various site QA, QC and RA proficiently.
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