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Associate II, Quality Assurance

3.00 to 4.00 Years   Chennai, Hyderabad   23 Mar, 2022
Finite HR Consulting Private Limited
Job LocationChennai, Hyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    About This Role Associate II is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities: Batch Records (Compounding, Filling, Visual Inspection and Packaging), Exceptions (Deviations, Alert/Actions) and CAPA. It is expected that this role will report directly into a Sr. Supervisor.What You ll Do
    • Product Disposition: Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
    • Exceptions, Complaints and CAPA: Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of the investigations and provides feedback to the department owner. Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect. Collaborates with associated departments to determine the appropriate
    Who You Are Looking for someone who is task driven and focused on taking action to resolve, remediate and/or improve. Collaborative person capable of being both agile and customer focused.,

Keyskills :
appliancescmshybrisj2eetask drivenbatch recordsquality assurancevisual inspectioncomplaint investigationsgmpagilefillingrecordsreviewsresearchstrategyassuranceoversight

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