Manoj Kumar Email and Phone Number

Responsible for providing Quality Assurance support for executing GMP manufacturing activities.Plan and coordinate review meetings to ensure the continuing suitability, adequacy and effectiveness of Quality system.Preparation of response & Coordinate and verify corrective and preventive actions taken against non-conformances observedduring audits.Spearheaded quality culture initiatives, promoting a "Right First Time" approach and excelled in handling investigations,Executing Media Fills, executing smoke studies & autoclave validation at site.Performed the Gap assessment of WHO TRS 1044 Annex 2, Revised Eudralex Volume 4 Annex 1 and Revised Schedule M,leading the project of implementing the identified actions during gap assessment.Designed approach, strategy and procedures for Sterility assurance monitoring and implemented the Sterility assuranceactivities at site.Developed the Contamination Control strategy at site and its effective implementation.Designing and developing contamination control strategy &implementation of effective procedures & practices to handle the critical process steps & aseptic manipulations.Evaluation, enhancement and validation of procedures/processes related to sterilization of product & components,disinfection of areas & validation of critical utilities.Personnel (entry/exit in aseptic areas, aseptic behavior and practices) & material movement controls (disinfection, integrity,conditions and flow).Monitoring utilization of existing resources & ensuring the implementation of various projects from time to time withindefined SLA.Responsible for Leading Sterility Assurance Group, Site Quality Management System, Site Vendor management, Site PlantTraining managementDesigning & implementing reskilling & multi-skilling training modules entailing GPM topics and employee behavior.Analyzing quality results to report error trends, root causes of errors & opportunities for defect reduction.

Leading Quality Management System, Plant Training management, Microbiology Laboratory compliance, Environmental Monitoring Program, & Service Provider QualificationsPlanning manpower requirements and identifying the right person through performance appraisal for organizational changeMentoring the team to complete various Process Improvement Projects while steering site inspection, equipment/inventory review, reports investigation, quality system management, and audit complianceIdentifying training needs; designing & implementing reskilling & multi-skilling training modules entailing GMP topics (21CFR Part 211, EudraLex Volume. 4 and Schedule M), data integrity, standard-specific documentation, and employee behavior

Head of Microbiology Laboratory

Handling Microbiology Laboratory functions, QMS and Environmental monitoring program

Management of Microbiology Laboratory and Environmental monitoring functions

Risk assessment, Change management, Instrument qualification, Method validations, Laboratory Start up, preparation of SOPs/STPs/Protocols etc.

Testing of pharmaceutical products and review of analytical documents, EM program

Testing of pharmaceutical products and review of analytical documents, EM program

Testing of pharmaceutical products and review of analytical documents, EM program