Ashwani Kumar Email & Phone Number

Punjab, India

Leading QA team to ensure constant state of compliance and audit readiness in alignment with current regulations and Quality Standards.● Providing technical direction in QA to achieve overall quality objectives.● Overseeing sterility assurance, including aseptic area monitoring, and ensuring non-conformances are reported, investigated, and resolved.● Reviewing and approving protocols and reports for process performance qualification, cleaning validation, hold time studies and Aseptic process simulation and other studies etc.● Reviewing and approving Quality risk assessments and ensuring that recommended action items are implemented.● Serving as lead auditor for external vendor audits and internal self-inspections.● Hosting regulatory audits and ensuring compliance with audit observations.● Reporting and escalating critical issues to appropriate management level for resolution.● Managing change control, deviation, investigation, OOS and CAPA system● Reviewing and approving GMP documents related to commissioning and qualification including IQ/OQ/PQ for facility, equipment and utilities.

Lalru, Punjab

Led validation, IPQA and QMS team for Vaccine block IV, Lines A, B, C, and D. Implemented robust quality measures by providing technical direction to achieve overall quality objectives.● Approved QMS elements such as change control, deviation, investigation, OOS, and managed monthly review meetings.● Served as Lead auditor for external vendor audits and internal self inspections.● Hosted regulatory audits and ensured compliance with audit observations.● Successfully managed the Brown Field project for modifications in the Vaccine Block, enabling the manufacturing of drug substances for the Covid vaccine “Sputnik Lite” and “Dengue monovalent drug substance” for scale-up batches.● Ensured compliance during the manufacturing of Dengue monovalent drug substance for Phase III trial batches (scale-up batches of 4 serotypes) and facilitated the submission of drug substance data to regulatory agencies.● Participated in the execution of Factory Acceptance Testing (FAT) for new equipment (seed and production scale fermenters).● Delivered Site master validation schedule for identified equipment within the stipulated timeline.

Ankaleshwar, Gujarat

Managed Supplier qualification activities (vendor qualification), audits, preparation of audit reports and review of CAPA response submitted by vendors. Oversaw internal self-inspections and external vendor audits, including audit report preparation and verification of CAPA responses. Hosted regulatory audits and prepared audit compliance reports. Reviewed QMS elements such as Change Control, Deviation, incident, OOS, Market complaints, Investigation and CAPA. Prepared monthly Quality review presentation and reports.

Ahmedabad, Gujarat, India

Implementation of Quality Management system - Change management, Deviation management, CAPA Management, process Investigation, Self inspection etc.To prepare Gap analysis report on Knowledge sharing on regulatory audit observations within the organization.Preparation of Validation Master Plan, to manage the validation plan as per schedule and to ensure the compliance with regulatory requirements.HVAC and equipment Qualification (IQ, OQ, PQ and re-qualification).To prepare and review of equipment / utility qualification documents and other study protocols.

Dehradun, Uttarakhand, India

Served as the Site Trackwise Coordinator for the Quality Management System, implemented eQMS a paperless solution. Logged and Reviewed change control, deviation, investigation, CAPA, market complaint. Conducted gap analysis on knowledge sharing, data (regulatory observation in other organizations). Prepared presentations and reports for monthly quality review meetings. Prepared the Site Master File, Quality manual, and QMS related SOP's.Additional responsibilities: Process Validation, Area Qualification, Equipment Qualification (washing machine, depyrogenation tunnel, Vial filling and bugging machine, vial capping machine, cold room etc), Media fill (aseptic simulation).

Baddi, Himachal Pradesh, India

Completed a Greenfield project for a new cephalosporin injectable line at Macleods Pharma Ltd., Unit VI, Baddi. Commissioning and qualification: Equipment and utilities qualification for example: steam sterilizers, vial washing machine, depyrogenation tunnel, vial filling and stoppering machine, HVAC systems, laminar air flows, dynamic pass boxes etc. Aseptic Process Simulations (Media Fills) by designing protocols, overseeing execution, and reviewing reports to ensure sterility assurance. Process validation activities, including protocol preparation, execution, report preparation and provide recommendation to production for critical manufacturing processes. In process Quality Assurance: Conducted line clearance in manufacturing and packing areas, Performed in-process, semi finished and finished product sampling.Verified dispensed raw materials, primary and secondary packing materials from warehouse, verified finished goods transfer ticket. Review of batch manufacturing records and packaging records to ensure compliance with GMP standards.

Baddi, Himachal Pradesh

Conducted line clearance, verified dispensed raw, primary and secondary materials. Performed in-process checks in manufacturing and packing areas. Reviewed batch manufacturing and packaging records and verified finished goods tickets. Collected samples from different stages of manufacturing and packing.Sampling during equipments and area re-qualification, process Validation etc.

B. Tech, Biotechnology, First Class

Activities and Societies: Cricket, Bioethanol production from waste. Production of wine from black grapes.During B. Tech in biotechnology.

M. Tech, Biotechnology, First Class

Activities and Societies: CricketDuring M. Tech in biotechnology, I studied Advance in Bioprocess technology (Handling of cell culture.