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Immediate opening For CQA position

10.00 to 20.00 Years   Hyderabad   01 Aug, 2021
Hetero
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Dear All,Greeting from Hetero BiopharmaWe have an opening for CQA (Biologics)Company Name: Hetero Biopharma LtdDepartment: CQA (Biologics)Designation: AGM/ DGMExperience: 12 to 18 yrs.Job Location: Jadcherla (Telangana)Job Responsibilities:

  • Responsible for Corporate Quality Operation for Biopharma facilities
  • Responsible for review and approval of corporate policies and core quality system procedures to ensure harmonization across the Biopharma Site/s
  • Updating the site/s with CGMP and current regulations from applicable regulatory guidelines and ensure compliance
  • Measuring the site/s Quality Metrics and Key Performance Indicators (KPI) and presenting to top management
  • Ensuring the data integrity compliance at site/s
  • Organizing the Management Quality Review meeting/s
  • Responsible for Site Inspection Management and Logistics
  • Responsible for ensuring the effectiveness of self-inspection programme at site/s
  • Responsible for preparing the Site Risk Management Program
  • Responsible for Vendor audit management
  • Responsible for training on the corporate policies / procedures of site key personnel
  • Supporting the plant QA team in various quality projects like E-Systems and CSV
  • Ensuring regulatory dossier compliance
  • Responsible for monitoring the quality systems and lab compliance of CGMP facilities and R&D facilities
  • Assure QbD (Quality by Design) Principles to ensure robustness of process and product
  • Review and Approval of Process Development, R&D and ARD Study Design, Work Protocols, Raw Data and Final Reports
  • Ensure stage gate compliance during product development and technology transfer
  • Supporting the R&D team for Product life cycle management
  • Team Co-ordination and team development
Interested candidates please share CV to edukondalu.m@heterodrugs.com ,

Keyskills :
product life cyclekey performance indicatorslife cyclevendor auditdata integrityquality systemrisk managementquality systemssite inspectionproduct developmentprocess developmentregulatory guidelinescqariskcgmpdesignvendormetrics

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