Mohit Kumar

Results-driven professional with extensive experience in operations management and quality assurance, adept at leading cross-functional teams to achieve operational excellence and ensure product/service quality. Proven track record of implementing strategic initiatives to optimize processes, reduce costs, and enhance overall efficiency. Strong leadership abilities with a focus on fostering a collaborative work environment to drive organizational success. Seeking a challenging role where we can leverage skills and expertise to contribute to the achievement of company objectives and deliver exceptional results.

• Assistant Manager (Quality Assurance Manager)- Current Role, Current Handling 3 different projects from all QA related Aspects., Preparation of SOPs and WIs., Creation and review of SOWs and MSA., Preparation & Review of QA reports & MBR (Monthly Business Review) and presenting to customer/client over teleconference., Creation & review of Business Continuity Plan & Disaster Recovery Plan, and ensure all BCP exercises performed timely (Simulation, Call tree, table top.. etc)., Lead the multiple Audit (CMS & MQA) & Assessments and successful closure of the same., Creation and review of Quality Management Process across multiple projects., Streamlined and enhanced the Document Control Process through system improvements., Preparation and submission of RCA/CAPA & 4 Square analysis in case of any deviation from the business agreement.
• Pharmacovigilance Subject Matter Expert (Drug safety unit), Training of new hires in projects., Responding to client/customers queries., Ensure all Service levels are met., Calibration activities to ensure the project is streamlined Random Audit on Final transaction and provide the feedback accordingly., Lead the feedback call/ training related meeting with Client.
• Pharmacovigilance Officer, Drug safety unit, Case intake through patients, their physicians, pharmacists or anyone who got information about the AEs, Handling of cases to submit AE reports, file product complaints or provide information about medicines., Documenting safety reports and product complaints through a computer based database system

ISO 9001 Lead Auditor.

Enthusiastic player of badminton, regularly engaging in recreational matches. Enjoy the physical activity, teamwork, and strategic thinking involved in the sport, fostering a balanced lifestyle and promoting physical fitness.