Greenfield Projects work of General Sterile Formulation Facility. (Team Size:110)• Small Volume Parenteral, Managing the project team responsible for commissioning, installation, qualification & Validation of injectable equipment's Qualification and Validations, system development, ExecutingProtocols of HVAC, Purified Water System, Pure Steam Generation system , Multi Column Distillation System Nitrogen Generation System, Facility & Equipment's.• Computer System Validation… Show more Greenfield Projects work of General Sterile Formulation Facility. (Team Size:110)• Small Volume Parenteral, Managing the project team responsible for commissioning, installation, qualification & Validation of injectable equipment's Qualification and Validations, system development, ExecutingProtocols of HVAC, Purified Water System, Pure Steam Generation system , Multi Column Distillation System Nitrogen Generation System, Facility & Equipment's.• Computer System Validation, Audit Trails review and verification and 21 CFRs compliance.• Cleaning validation, CIP, SIP, Protocol Review, Worst Case Identification, Protocol Preparation, review and verification.• Strategic Management division related to internal system development. Responsible for the overall technical and Managing operations of the Quality System in various departments including technical inputs to enhance Quality Operation & System.• Well versed in Audit preparation and compliance, Able to maintain the Manufacturing Site any time readiness for Audit without any GMP issues. Show less

Expert in Aseptic process and manufacturing, trouble shooting and problem solving expertise in sterile manufacturing, day to day coordinator with production, Micro, QC and Engineering department to achieve quality products, schedule qualification monitoring of sterile equipment and utilities for timely delivery of quality products., BMS, SCADA monitoring, Controlling, investigation through QMS tool and CAPA and resolve trouble shooting.

Torrent has three world-class manufacturing facilities at Indrad (Gujarat), Baddi (Himachal Pradesh) and Sikkim. The facilities are approved by USFDA, WHO, MHRA, TGA and other global regulatory bodies.Torrent Pharma has a strong international presence spanning over 40 countries with over 1200 product registrations. It has wholly owned subsidiaries in USA, UK, Germany, Brazil, Russia, Mexico, Philippines and other major markets. These wholly owned subsidiaries spearheads the company’s entry… Show more Torrent has three world-class manufacturing facilities at Indrad (Gujarat), Baddi (Himachal Pradesh) and Sikkim. The facilities are approved by USFDA, WHO, MHRA, TGA and other global regulatory bodies.Torrent Pharma has a strong international presence spanning over 40 countries with over 1200 product registrations. It has wholly owned subsidiaries in USA, UK, Germany, Brazil, Russia, Mexico, Philippines and other major markets. These wholly owned subsidiaries spearheads the company’s entry into several new regulated and semi regulated international markets. Show less

Key Responsibilities: Successfully faced WHO GENEVA AUDIT, Responsible for overall QA activities, QA Compliance, Responsible for Harmonization of systems & procedures, Managing validation, qualification team, Handling External Audits,

Preparation of Apex documents like i.e Site Master File, Quality Manual, Validation Master Plan and their update form time to time.Preparation and Reviewing of Cleaning Validation Protocol, Matrix, Report and giving training for Execution of protocol to cleaning validation team.Preparation and Reviewing of Process Validation Protocols and Process Validation Reports and giving training for Execution of protocol to process validation team.Preparation and Reviewing of Qualification… Show more Preparation of Apex documents like i.e Site Master File, Quality Manual, Validation Master Plan and their update form time to time.Preparation and Reviewing of Cleaning Validation Protocol, Matrix, Report and giving training for Execution of protocol to cleaning validation team.Preparation and Reviewing of Process Validation Protocols and Process Validation Reports and giving training for Execution of protocol to process validation team.Preparation and Reviewing of Qualification documents HVAC System (Class A, B ,C, D), Water System (PW & WFI) giving training for Execution of protocol to Qualification team.Preparation Weekly and Monthly Report.Preparation of Qualification Protocol of Critical equipments such as chiller, compresed Air, Thermal mapping, vail & ampoule filling & sealing machine, DHS, Autoclave. Training imparted on Various Topics of GMP, on-job and technical.Reviewing of SOPs and other GMP documents.Work as team leader for validation of Water Generation and Distribution, Tablets, Capsules, Dry Syrup, Suspension Process Validation.Vendor Qualification and Management and Conducting Vendor Audit of Critical Raw and Packing Materials. Show less

Preparation of Site Master File, Quality Manual, Validation Master PlanPreparation and Execution of Training programme Technical training and maintain records.Preparation of Process Validation Protocols and Process Validation Reports.Reviewing of Qualification HVAC System, Water System and Equipments.Preparation Weekly and Monthly Report.Preparation of self inspection Schedule, and coordinate with other department for execution of SI as per schedule. Training imparted on… Show more Preparation of Site Master File, Quality Manual, Validation Master PlanPreparation and Execution of Training programme Technical training and maintain records.Preparation of Process Validation Protocols and Process Validation Reports.Reviewing of Qualification HVAC System, Water System and Equipments.Preparation Weekly and Monthly Report.Preparation of self inspection Schedule, and coordinate with other department for execution of SI as per schedule. Training imparted on Various Topics of GMP.Reviewing of SOPs and other GMP documents Show less

Document & Data Control, Handling of Deviation, Change Control & Market Complaints.Preparation, Issuance, Retrieval and Execution of SOPs and Training.Preparation of Process Validation Protocols and Process Validation Reports.Preparation of HVAC System qualification documents.Preparation of Annual Product Quality Review (APQR).Preparation of Validation Master Plan.Preparation of Equipment Qualification Protocol. Preparation and Execution of Cleaning Validation… Show more Document & Data Control, Handling of Deviation, Change Control & Market Complaints.Preparation, Issuance, Retrieval and Execution of SOPs and Training.Preparation of Process Validation Protocols and Process Validation Reports.Preparation of HVAC System qualification documents.Preparation of Annual Product Quality Review (APQR).Preparation of Validation Master Plan.Preparation of Equipment Qualification Protocol. Preparation and Execution of Cleaning Validation Protocol, Matrix and Report.Preparation of Qualification Documents of Various Equipments. Show less

Document Issuance & ControlIPQA activity on shop floorPreparation of BMR/BPR reviewing of STP. Specifications and Protocols.Preparation of Licenses & Registration Documents for Regulatory Authorities.Review of BMR & BPRMonitoring of Dispensing activity for Raw, Packaging materials and Line clearance of all production activities Preparation and update of Vendor List.