Maulin Rathod, MSc, PMP, CSCP

Ensuring product life cycle management through a process control from receipt of raw material to dispatch of the finished product as per the Quality Management System, HACCP and SQF standards. Compliance / Documentation  Ensuring that all quality incidents are properly documented and the appropriate people notified/kept informed  Ensuring that Standard Operating Procedures are being followed as written; any deviations are approved and supported by documentation.  Monitoring and enforcing compliance with GMP standards  Preparing QA documentation for HACCP, SQF, and Drug licenses as required.  Ensuring all QA documentation is in compliance with customer requirements

Successfully Planned and implemented new product development, with completion of process validation, cleaning validation, Hold time study and document change control as per product specific validation master plan. Ensured process control and continuous improvement through cGMP compliance,Deviations management ,, Internal audits,Handling of market complaints,implementation and review of corrective and preventive actions (CAPA management). Trained staff members and employees on quality management systems and lean manufacturing. Driven successful business by cost savings on product change over time management and schedule management. Member of ISPE india Affiliate, successfully attended courses on QMS & PQLI.

Successfully implemented various medical devices manufacturing projects as per the ISO 13485 regulation ■ Carried out Trial batches and process validation batches. ■ Validated moist heat sterilization for stop bleeding solution and sterilization of Stop bleeding Tulle by gamma radiation conducted at ISOMED –Mumbai. ■ provided guidance on documentation preparation like design history files, Standard Operating Procedures, work instructions and records. ■ Imparted job specific training to all concerned. ■ Conducted internal audits, review meetings, planning and execution of Third party audits.

Overall implementation of the Quality Management System. Monitoring of CCPs and Confirmation of effectiveness of HACCP. Microbial environmental and RM,FP testing as per the Pepsi Cola approved methods. Ensure the product quality in comparison with Pepsi Cola standards. Data entry of results in Statistical Process Control system(M&W).