Responsible for the qualification and validation of facilities, utilities,processes, cleaning and equipments, documentation and implementation of site validation master plan related to 12 JulpharSterile plants.Verification of design qualification and related documents for equipments. i.e. URS, DQ, FDS, FAT and SAT.Ensure all GxP computerized systems are appropriatelydocumented and validated.Investigation of the incidents, OOS, deviations and allmanufacturing related non conformances with respect tovalidations, Change control and CAPA action plans review and closure.SME for thermal validatie , operation of Kaye and Ellab Validators.Liaises with other departments for creative quality culture.

Leads a team of talented QA executives and officers involved in Compliance, Validation & Documentation activities over Production Sterile Operations.In charge of overseeing multiple QA jobs simultaneously including Handling of QMS Related to Qualification and Validation, Supplier Evaluations, Validation & Qualifications, Inspection & Audits along with Documentation & Data Control Administration.Responsible for conducting Internal Audits of process and utility area.Responsible for Handling of Regulatory Audits.Responsible for preparation of QRM Related to Equipment, Utilities and Facilities.Responsible for Preparation and Execution of Master Validation Plan.Responsible for Procurement of Materials required for Qualification and Validation Activites.Operation of SAP for Procurements (CAPEX and OPEX Materials)Liaises with other departments for creative quality culture.

➢ Involved in cleaning and process validation activities.➢ Exposure in modified facility commissioning and installation of injectable line i.e. Liquid & Lyophilized.➢ Responsible for Planning of Validation/Qualification Strategy and Approach as per Validation MasterPlan.➢ Responsible for preparation and review of facility layouts.➢ Responsible for Preparation and Review of Qualification Protocol (IQ, OQ, PQ and RQ) and Reports ofall Process Equipment and Facility.➢ Responsible for Preparation and Review of Equipment Qualification Document (Like: UserRequirement Specification, Basic Risk Assessment, Impact Assessment to identify the extentqualification and Detailed Risk Assessment).➢ Responsible for execution of Installation, Operational & Performance qualification of equipments.➢ Responsible for preparation of shop floor related SOPs of QA.➢ Responsible for review and execution of SIP validation, autoclave validation, Freeze dryer (Lyophilizer),Depyrogenation Tunnel and Vial filling, Stoppering and Sealing Machine with CRABS documents.➢ Responsible for operation of Kaye Validator (AVS & V2K).➢ Responsible for programming of Testo data loggers and execution of Temperature mapping Study within-house data loggers.➢ Responsible for HVAC/Area Qualification and all HEPA filters Equipments validation.➢ Compilation of Qualification and Validation executed reports.

➢ Exposure in initial facility commissioning and installation of injectable line i.e. Liquid & Lyophilized.➢ Responsible for Planning of Validation/Qualification Strategy and Approach as per Validation MasterPlan.➢ Responsible for preparation and review of facility layouts.➢ Responsible for Preparation and Review of Qualification Protocol (IQ, OQ, PQ and RQ) and Reports ofall Process Equipment and Facility.➢ Responsible for Preparation and Review of Equipment Qualification Document (Like: UserRequirement Specification, Basic Risk Assessment, Impact Assessment to identify the extentqualification and Detailed Risk Assessment).➢ Responsible for execution of Installation, Operational & Performance qualification of equipments.➢ Responsible for preparation of shop floor related SOPs of QA.➢ Responsible for review and execution of SIP validation, autoclave validation, Freeze dryer (Lyophilizer),Depyrogenation Tunnel and Vial filling, Stoppering and Sealing Machine with CRABS documents.➢ Responsible for operation of Kaye Validator (AVS & V2K).➢ Responsible for programming of Testo data loggers and execution of Temperature mapping Study within-house data loggers.➢ Responsible for HVAC/Area Qualification and all HEPA filters Equipments validation.➢ Compilation of Qualification and Validation executed reports.

➢ Responsible for HVAC/Area Qualification and all HEPA filters Equipments validation.➢ Responsible for Preparation and Review of Equipment Qualification Document.➢ Responsible for communication with Third party for Certificates and execution planning.➢ Compilation of Qualification and Validation executed reports.