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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD |
EmploymentType | Full-time |
Preparation and review of QA SOPS and other documentationCompliance of product specifications and test procedures against applicable guidance documentsApproval of method qualification protocolsCoordination with respective development teams for material requirementsApproval of specifications with vendor qualification activitiesReview of facility or utility monitoringResponsible for compliance of GMP during clinical trialsCoordination with cross functional teams for submission of samples for various studiesReview of documents for regulatory dossiersleApproval of protocols related to process and testingApproval of layouts qualification protocols of facility and equipmentApproval of Batch Production Records.Operating Network Internal : QA, R&D, tech. dev, project management, RA, and other functional experts.External : Vendors, Regulatory agencies, partners, expertsTechnical Requirements : Knowledge on development of different vaccines, knowledge on clinical studies, documentation control managementKey personal competencies : Team management, good communication skills, presentation skills, problem solving skills, and decision making and critical thinking.,
Keyskills :
teammanagementproblemsolvingtestproceduresmatrixleadershipprojectmanagementpresentationskillscommunicationskillstechnicalrequirementsgmpcontrolegulatyagenciesvendqualificationvendvend