Manoj Kumar Jangir Email and Phone Number

Extensive experience in handling Injectables Green field projects and commissioning, qualification and validation of newequipment.Expertise in Isolator, Lyophilization technology, Complex Injectables manufacturing such as Microspheres/Lyposomes.Demonstrated ability to lead aseptic operation of two filling line,Excellent understanding of validation principles and methodologies, including IQ, OQ, PQ, and CSV of filling line Equipment.Deep and showed understanding and experience of the principles of Annex 1 and how they translate into a contaminationcontrol strategy for vial and syringe filling employing isolator technology.Having knowledge of current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area.Deep technical knowledge of Sterile Drug Product manufacturing both from a process and equipment perspective. Specifically,in the areas of sterile filling and associated equipment.Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineeringbatches,exihibit batches and .commercial batches.Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives, e.g., SixSigma.Experience in leading & resolving complex technical investigations.Experience in a risk-based approach to manufacturing through use of tools such as FMEA.Self-driven, result-oriented, positive outlook and a clear focus on businessStrong knowledge of regulatory requirements and guidelines, including FDA and EU guidelines.Extensive experience in handling of routine and non routing interventions.Maintain production schedules, timecards, documentation requirements, etc.Proficient in using software such as TrackWise and SAPProficient in performing risk assessments and developing validation strategiesProven ability to manage multiple validation projects simultaneously and meet tight deadlines

Handling Green field Project. Manpower planning, budgeting and recruitment process, Commissioning, Qualification &validation of new equipment as per project plan.Handling of Technology transfer batches, Exhibit batches, Internal Audits, Regulator Audits.Preparation and Review of QMS documents like change control, incident reporting, failure investigation, audit compliance,qualification validation protocols and reports (supporting utilities, equipment), aseptic media fill studies, risk assessment, Userrequirement specification etc.

New equipment procurement, commissioning and qualification in green field project of sterile manufacturing facilityQA support for validation investigations and implementation of corrective actions.Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and softwarein compliance with policies, FDA, European cGMP and GAMP standards.Generation of validation protocols and final reports to cGMP standards.Facilitating audits and regulatory inspections.Liaising with external vendors, contractors or suppliers to ensure that their products or services meet the organization's qualitystandard