Immediate opening For CQA position

from 10 to 20 year(s) of Experience
₹ Not Disclosed by Recruiter

Job Description

Dear All,


Greeting from Hetero Biopharma


We have an opening for CQA (Biologics)


Company Name: Hetero Biopharma Ltd


Department: CQA (Biologics)


Designation: AGM/ DGM


Experience: 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

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Other

Role Category:Other

Employment Type:Full Time, Permanent

Education-

PG:Any Postgraduate

Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
View Contact Details+

Contact Company:Hetero Drugs Limited

Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India

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