Satish Kashyap Email and Phone Number

 Designing Quality System by closely working with individual department and Institution of compliance programs at site. Designing and Implemented Electronic Quality Assurance management system such as Permanent change control, Temporary change control, Deviation, Investigation, Market complaint, CAPA, OOS, OOT, Control sample and Stability Management) and Document Management System (SOP’s, Level – I Documents & Protocols). Developed and implemented high level of policy document for Data Integrity and its Governance. Institution of Gap Assessment and ensure the compliance for USFDA, EU GMP, UK MHRA, Australia TGA, Brazil ANVISA and WHO-Geneva at site. Harmonization and implementation of Quality system at plant level as per the regulatory guidelines. Leadership team on regulatory audits and response to audit compliance.  Conducting the review and approval of Internal Audit and its compliance. Responsible for the management of vendor audit and its compliance. Management and review of Quality management system (Permanent Change control, Temporary change control, Deviation, CAPA, Market complaint, Product Recall, OOS & OOT etc.). Institution of validation and qualification strategy (cleaning validation, process validation, equipment qualification, HVAC Qualification and Utilities qualification) and its implementation at site for regulatory compliance.  Training and development of personnel. Played a leadership role in Quality Management System in site quality operations. Conducting Quality Risk Assessment and tracking the mitigation plan to fix the gaps. Leading the team for the introduction of new products at site as developed by R&D.

Designing Quality System by closely working with individual department and Institution of compliance programs at site. Harmonization and implementation of Quality system at plant level as per the regulatory guidelines.Institution of Gap Assessment and ensure the compliance for US FDA, EU GMP, UK MHRA, Australia TGA, Brazil ANVISA and WHO-Geneva at site. Implementation of quality tools such as Ishikawa 6Ms/4Ps, FMEA, Why-Why Analysis and Statistical analysis of data through Minitab software. Leadership team on regulatory audits and response to audit compliance. Conducting the review and approval of Internal Audit and its compliance.Responsible for the management of vendor audit and its compliance.Responsible for the Quality management system reviewInstitution of validation and qualification strategy (cleaning validation, process validation, equipment qualification, HVAC Qualification and Utilities qualification) and its implementation at site for regulatory compliance. Conducting risk assessment for the each unit of operation, Risk review with mitigation plan. Training and development of personnel. Played an leadership role in Quality Management System in site quality operation

Identify the gaps in the system and Deploying current validation standards in view of regulatory requirementsConducting training on qualification, validation, aseptic process simulation, clean room behaviors etc., Institution of cross contamination strategy (as Betalactum, Cephalosporin and General Block in single premise) and its implementation at site for regulatory compliance. Successfully cleared US FDA, UK MHRA, WHO-Geneva & Latvia, GCC, and customer audits.

Equipment / Instrument Qualification and Validation.Area Qualification and Line clearance for aseptic process operation. Water System Qualification and Validation.Aseptic Process Validation by Media Fill Activities.HVAC Qualification and Validation.Temperature mapping study of warehouse.Utility Qualification such as Compressed air, Pure steam , Nitrogen, Purified water, WFI and its Validation

Designing Quality System by closely working with consultants such as Mr. Peter Monger from UK and Mr. David Bucklay from Australia.Institution of Gap Assessment and ensure the compliance for US FDA, EU GMP, UK MHRA, Australia TGA, Brazil ANVISA and WHO-Geneva at sites. Implementation of quality tools such as Ishikawa 6Ms/4Ps, FMEA, Why-Why Analysis and Statistical analysis of data through Minitab software. Leadership team on regulatory audits and response to audit compliance. Institution of validation and qualification strategy (cleaning validation, process validation, equipment qualification, HVAC Qualification and Utilities qualification) and its implementation at site for regulatory compliance.

Handling of Change control and Deviation. Issuance, Review and Control of BMR and BPR.Issuance, Review and Control of Documents.Handling of Control Sample Release of Finished Goods.Participated in Process Validation and Equipment Qualification

In-Process Quality Assurance Issuance, Review and Control of BMR and BPR.Issuance, Review and Control of Documents.Handling of Control Sample Release of Finished Goods.