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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Biological E Limited : Celebrating Life Every Day Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around Rs.1100 crore and employee strength of around 2000. It is growing at around 36% CAGR. Its intellectual pool of experienced scientist are based out of India and France. BE has state - of - the - art manufacturing sites in India (Hyderabad and Dehradun).Academic Background and Experience MSc Life Sciences with 2 to 6 years of experience.Job responsibilities 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. Internal : QA, R&D, tech. dev, project management, RA, and other functional experts.External : Vendors, Regulatory agencies, partners, experts Technical 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 :
continuousimprovementfacilitation lifesciences teammanagement problemsolving testprocedures matrixleadership projectmanagement presentationskills academicbackground communicationskills egulat yagencies