Nilesh Mishra

About Nilesh Mishra

Result-oriented professional with more than 20 years of experience in managing overall…

Experience

1. Associate Director Qa

   Cipla

   Dec 2023 — Present · IN

   Played a key role in various GMP audits like – USFDA, MHRA, EU GMP, ANVISA, TGA, German FDA, Uganda, Turkey,WHO, Russia and many more consultant/customer auditsMonitoring and Measuring the Quality index through Product Quality, Deviations, Change Control, CAPA, OOS, Failure Investigations & other parameters and driving process re-engineering initiativesSubject Matter expert in Sterility Assurance, Validation, Investigation, Quality Risk Management and Gap Analysis in Injectable operationsExperienced in Remediation of sterile facility including Assessment of sterility assurance level, designing aseptic process, Smoke study, Media fill and coordination with consultants.Excels in developing & maintaining quality engineering methodologies, systems, and practices which meet customer & regulatory requirementsLeading Quality Assurance function of a sterile and liquid oral manufacturing unit, supplying to Global market.Ensuring effective implementation of Quality management system as per regulatory and Cipla global standard requirements.Continuous improvement and review for upgrading existing SOPs, quality policy and systems with respect to compliance to global standards.Conduct periodic quality management review of process performance, key performance indicators and submission of review report to senior management.Ensure review & timely response to regulatory communications.Leading post WL remediation activities.To coordinate and execute all customer / regulatory audits and monitor compliance to audit observation and cGMP requirement.Monitor and approval of Quality Metrics Score card.Approval / rejection of starting materials, packaging materials and bulk product, finish products.Recruitment, retention, supervision and motivation of personnel.Investigate the data integrity issues identified along with investigation team, ensuring adequate impact assessment and implement necessary CAPA.