Quality Management System (QMS)Handling of Change Controls, Annual Product Quality Review, Investigation of Out of Specification (OOS) events and Deviations, Malfunctions, Planning and Implementation of CAPA, Quality Risk Assessment, Process and Analytical Method Validation, Computer System validation, Qualification of system and equipmentAudit & Compliance Handling of Internal (self Inspection) & External Audits, Vendor Qualification (Initial Assessment, Approval of vendor by… Show more Quality Management System (QMS)Handling of Change Controls, Annual Product Quality Review, Investigation of Out of Specification (OOS) events and Deviations, Malfunctions, Planning and Implementation of CAPA, Quality Risk Assessment, Process and Analytical Method Validation, Computer System validation, Qualification of system and equipmentAudit & Compliance Handling of Internal (self Inspection) & External Audits, Vendor Qualification (Initial Assessment, Approval of vendor by facility audit), Qualification of Quality Contract laboratories.Exposed to Regulatory Audits and compliance like; EU GMP – EMEA, ANVISA (Brazil), Syria FDA, WHO, FDA Gujarat, NIB (New Delhi).QS DocumentationPreparation & Review of GMP relevant documents i.e. Site Master File, Validation Master Plan, Technology Transfer Document (TTD), Annual Product Quality Review (APQR), Batch Record Review, Standard Operating Procedure, Validation / Qualification Protocols & Reports, Material Specification, Standard Test ProceduresValidation/QualificationEquipment Qualification, Analytical Method Validation, Internal Reference Standard Qualification, Process and Cleaning Validation, Analyst Qualification, HVAC and Water System ValidationAnalytical skillPhysico-chemical and Instrumental analysis of various Biotherapeutic protein, Raw Materials, and water for Injection. Show less

Handling of External Audits (Regulatory, Vendor/supplier Qualification, and Qualification of Quality Contract labs), Handling & Investigation of Deviations, Handling of Change controls, Annual Product Quality Review, Quality Risk Assessments. Review of SOPs, Technical Specifications, Technology Transfer Documents, Written Procedures, Analytical Method Validation Protocol and Reports, Stability Protocol and Reports, Test Reports and other GMP documents.Organizing continuous… Show more Handling of External Audits (Regulatory, Vendor/supplier Qualification, and Qualification of Quality Contract labs), Handling & Investigation of Deviations, Handling of Change controls, Annual Product Quality Review, Quality Risk Assessments. Review of SOPs, Technical Specifications, Technology Transfer Documents, Written Procedures, Analytical Method Validation Protocol and Reports, Stability Protocol and Reports, Test Reports and other GMP documents.Organizing continuous Internal audits to ensure GLP / cGMP compliance and ensuring that teams adhere to all quality standards & procedures by conducting In-process Quality Assurance monitoring.Imparting cGMP & SOPs training.Reviewing of CMC section of CTD & GAP analysisDocument Management Show less

Handling of External Audits (Regulatory, Vendor/supplier Qualification, and Qualification of Quality Contract labs), Handling & Investigation of Deviations, Handling of Change controls, Annual Product Quality Review, Quality Risk Assessments. Review of SOPs, Technical Specifications, Technology Transfer Documents, Written Procedures, Analytical Method Validation Protocol and Reports, Stability Protocol and Reports, Test Reports and other GMP documents.Organizing continuous… Show more Handling of External Audits (Regulatory, Vendor/supplier Qualification, and Qualification of Quality Contract labs), Handling & Investigation of Deviations, Handling of Change controls, Annual Product Quality Review, Quality Risk Assessments. Review of SOPs, Technical Specifications, Technology Transfer Documents, Written Procedures, Analytical Method Validation Protocol and Reports, Stability Protocol and Reports, Test Reports and other GMP documents.Organizing continuous Internal audits to ensure GLP / cGMP compliance and ensuring that teams adhere to all quality standards & procedures by conducting In-process Quality Assurance monitoring.Imparting cGMP & SOPs training.Document Management Show less

Preparation of Standard Operating Procedure, Protocol & Reports.Preparation of Material Specification, Standard Test Procedure according to pharmacopoeial requirement.Management of In-coming samples for QC analysisManagement of Control and Retention samplesManagement and analysis of Stability Samples Analysis of In-process, Drug Substance, Drug Product samples of various Biotherapeutic proteins (i.e. G-CSF, Peg G-CSF, Erythropoietin, Interferon… Show more Preparation of Standard Operating Procedure, Protocol & Reports.Preparation of Material Specification, Standard Test Procedure according to pharmacopoeial requirement.Management of In-coming samples for QC analysisManagement of Control and Retention samplesManagement and analysis of Stability Samples Analysis of In-process, Drug Substance, Drug Product samples of various Biotherapeutic proteins (i.e. G-CSF, Peg G-CSF, Erythropoietin, Interferon alfa-2b)Sampling & Analysis of Starting and Packing MaterialCalibration / Validation of various QC equipments i.e. HPLC, UPLC, spectrophotometer, analytical balance etc.Validation / Verification of Analytical Method Development of Internal Reference standard Cold chain development & shipper validationMaintaining of GLP/GMP document & fulfill audit and regulatory requirementArtwork Analysis and Vendor Qualification Show less